ASCEND: A Study of Cardiovascular Events iN Diabetes
Sponsor
University of Oxford (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00135226
Collaborator
British Heart Foundation (Other), Bayer (Industry), Medical Research Council (Other), Solvay Pharmaceuticals (Industry), Abbott (Industry), Mylan (Other)
15,480
1
4
389
39.8
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether 100mg daily aspirin versus placebo and/or supplementation with 1 gram daily omega-3 fatty acids or placebo prevents "serious vascular events" (i.e. non-fatal heart attack, non-fatal stroke or transient ischaemic attack, or death from vascular causes) in patients with diabetes who are not known to have occlusive arterial disease and to assess the effects on serious bleeding or other adverse events.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The role of antiplatelet therapy (chiefly aspirin) for the secondary prevention of heart attacks and strokes is firmly established for many high-risk people with diagnosed arterial disease, and the proportional reductions in these cardiovascular events appear to be about one quarter, whether or not such patients have diabetes. But, most younger and middle-aged people with diabetes do not have manifest arterial disease - although they are still at significant cardiovascular risk - and yet few trials have tested aspirin in such individuals. As a result, there is substantial uncertainty about the role of aspirin for the prevention of heart attacks and strokes among apparently healthy people with diabetes, and only a small minority receives it.
There is consistent evidence from observational studies of lower rates of cardiovascular disease (particularly cardiac and sudden death) in people with higher intakes, or higher blood levels, of fish oils (omega-3 fatty acids). Trials in people who have survived a heart attack have shown modest, but potentially worthwhile, reductions in coronary events.
If ASCEND can reliably demonstrate that aspirin and/or fish oils safely reduce the risk of cardiovascular events and deaths in people with diabetes who do not have pre-existing arterial disease, then this would be relevant to some tens of millions of people world-wide (who are currently not receiving such therapy) and might save tens of thousands of lives each year.
The initial results (published 2018) showed that aspirin prevented serious vascular events in patients with diabetes who did not already have cardiovascular disease, but it caused almost as many major bleeds and there was no effect on cancers. There was no significant difference in the risk of serious vascular events between those who were assigned to receive n-3 fatty acid supplementation and those who were assigned to receive placebo.
ASCEND will be conducting long-term follow-up for 20-years beyond the scheduled treatment period (which ended in 2017). We will collect relevant data from UK central health registries. This will be used to assess whether the balance of benefits versus hazards of aspirin observed within the main trial, relating to major vascular events such as heart attack or stroke, continue long-term or whether additional benefits emerge during longer-term follow-up.
In addition ASCEND will use this long-term post-trial follow-up to investigate further whether low-dose aspirin might protect against cancer. The main cancer analyses is planned to take place ~5-years after the end of the treatment period.
Study Design
Study Type:
Interventional
Actual Enrollment
:
15480 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Study of Cardiovascular Events iN Diabetes - A Randomized 2x2 Factorial Study of Aspirin Versus Placebo, and of Omega-3 Fatty Acid Supplementation Versus Placebo, for Primary Prevention of Cardiovascular Events in People With Diabetes
Study Start Date
:
Mar 1, 2005
Actual Primary Completion Date
:
Mar 12, 2018
Anticipated Study Completion Date
:
Jul 31, 2037
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Aspirin + Omega-3 Ethyl Esters Participants receive 100mg of aspirin once daily and 1g of omega-3 ethyl esters once daily. |
Drug: Aspirin
Drug: Omega-3 Ethyl Esters
Other Names:
|
| Active Comparator: Aspirin + Placebo Omega-3 Ethyl Esters Participants receive 100mg of aspirin once daily and placebo omega-3 ethyl esters once daily. |
Drug: Aspirin
Drug: Placebo Omega-3 Ethyl Esters
|
| Active Comparator: Placebo Aspirin + Omega-3 Ethyl Esters Participants receive placebo aspirin once daily and 1g of omega-3 ethyl esters once daily. |
Drug: Omega-3 Ethyl Esters
Other Names:
Drug: Placebo Aspirin
|
| Active Comparator: Placebo Aspirin + Placebo Omega-3 Ethyl Esters Participants receive placebo aspirin once daily and placebo omega-3 ethyl esters once daily. |
Drug: Placebo Aspirin
Drug: Placebo Omega-3 Ethyl Esters
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With First Occurrence of Any Serious Vascular Event (SVE) [Randomized treatment phase during a mean of 7.4 years]
The primary efficacy assessments involve intention-to-treat comparisons among all randomized participants of allocation to aspirin versus placebo and, separately, of omega-3 fatty acids versus placebo on the first occurrence of any "Serious Vascular Event" (SVE), defined as: non-fatal myocardial infarction; or non-fatal stroke (excluding confirmed intracranial hemorrhage) or TIA; or vascular death excluding confirmed intracranial hemorrhage (defined as International Classification of Diseases 10th revision [ICD-10] I00-52 or I63-99, i.e. excluding subarachnoid hemorrhage [I60], intracerebral hemorrhage [I61], and other non-traumatic intracranial hemorrhage [I62]).
- Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only) [Randomized treatment phase during a mean of 7.4 years]
The primary safety assessments involve intention-to-treat comparisons among all randomized patients of allocation to aspirin versus placebo on the first occurrence of "any major bleed", defined as: any confirmed intracranial hemorrhage (including intracerebral, subarachnoid, subdural or any other intracranial hemorrhage); or sight-threatening eye bleeding; or any other serious bleeding episode.
Secondary Outcome Measures
- Number of Participants With Combined End-point of Serious Vascular Events (SVEs) or Revascularizations [Randomized treatment phase during a mean of 7.4 years]
Secondary efficacy assessments involve intention-to-treat comparisons among all randomized participants of allocation to aspirin versus placebo and, separately, of omega-3 versus placebo on the first occurrence of the expanded vascular endpoint of "SVE or revascularization" (including coronary and non-coronary revascularizations).
- Number of Participants With Any Incident Gastrointestinal (GI) Tract Cancer (Aspirin Comparison Only) [Randomized treatment phase during a mean of 7.4 years]
Secondary efficacy assessments of aspirin involve intention-to-treat comparisons during the scheduled treatment period among all randomized participants on the first occurrence of: Any incident gastrointestinal (GI) tract cancer (i.e. any GI cancer excluding pancreas and hepatobiliary), overall and after exclusion of the first three years of follow-up.
Other Outcome Measures
- Number of Participants With Fatal Event: All-cause Mortality [Randomized treatment phase during a mean of 7.4 years]
'All-cause mortality' includes all recorded deaths.
- Number of Participants With Fatal Event: Coronary [Randomized treatment phase during a mean of 7.4 years]
Fatal 'Coronary' events include deaths from: Acute MI and other CHD (unspecified Acute ischaemic heart disease; Atherosclerotic heart disease; Ischaemic cardiomyopathy; unspecified Chronic ischaemic heart disease).
- Number of Participants With Fatal Event: All Stroke [Randomized treatment phase during a mean of 7.4 years]
Fatal 'All stroke' events include deaths from: Haemorrhagic stroke (Intracerebral haemorrhage; Subarachnoid haemorrhage); Non-haemorrhagic stroke (Cerebral infarction; Stroke not specified as haemorrhage or infarction).
- Number of Participants With Fatal Event: Other Vascular [Randomized treatment phase during a mean of 7.4 years]
Fatal 'Other vascular' events include deaths from: Heart failure (excluding ischaemic cardiomyopathy); Other vascular death (excluding stroke; and Cardiac death (excluding CHD).
- Number of Participants With Fatal Event: Cancer [Randomized treatment phase during a mean of 7.4 years]
Fatal 'Cancer' events include any death attributed to cancer.
- Number of Participants With Fatal Event: Respiratory [Randomized treatment phase during a mean of 7.4 years]
Fatal 'Respiratory' events include any death attributed to respiratory causes.
- Number of Participants With Fatal Event: Other Medical [Randomized treatment phase during a mean of 7.4 years]
Fatal 'Other medical' events include deaths from: Non-vascular medical causes (excluding cancer and respiratory, including Fatal GI bleed or perforation); and deaths from Renal disease and Diabetes.
- Number of Participants With Fatal Event: External Cause [Randomized treatment phase during a mean of 7.4 years]
Fatal 'External cause' events include deaths from: Injury; Fracture; Self harm; and Medical and surgical complications
- Number of Participants With Fatal Event: Unknown Cause [Randomized treatment phase during a mean of 7.4 years]
Any death for which the cause is not known.
- Number of Participants With Event: Any Cancer [Randomized treatment phase during a mean of 7.4 years]
Incidence of fatal or non-fatal cancers. Any cancer excludes non-fatal non-melanoma skin cancer and non-fatal recurrence of a cancer that had occurred before randomization. A single participant may have had multiple cancers.
- Number of Participants With Event: Other Gastrointestinal Cancer (Aspirin Comparison Only) [Randomized treatment phase during a mean of 7.4 years]
Includes fatal and non-fatal cancers. Excludes cancers reported in the gastrointestinal tract category (see secondary outcome measure #4), and includes hepatobiliary and pancreatic cancers.
- Number of Participants With Event: Respiratory Cancer [Randomized treatment phase during a mean of 7.4 years]
Includes fatal and non-fatal cancers. Includes lung and larynx cancer.
- Number of Participants With Event: Genitourinary Cancer [Randomized treatment phase during a mean of 7.4 years]
Includes fatal and non-fatal renal, bladder, prostate, gynaecological and other GU cancers
- Number of Participants With Event: Hematological Cancer [Randomized treatment phase during a mean of 7.4 years]
Includes fatal and non-fatal cancers. Includes leukaemia and lymphoma.
- Number of Participants With Event: Breast Cancer [Randomized treatment phase during a mean of 7.4 years]
Includes fatal and non-fatal cancers.
- Number of Participants With Event: Melanoma [Randomized treatment phase during a mean of 7.4 years]
Includes fatal and non-fatal melanomas.
- Number of Participants With Event: Other Cancer [Randomized treatment phase during a mean of 7.4 years]
Includes fatal and non-fatal cancers not included elsewhere (where the type of cancer is known).
- Number of Participants With Event: Unspecified Cancer [Randomized treatment phase during a mean of 7.4 years]
Includes fatal and non-fatal cancers of unknown type.
- Number of Participants With Event: Atrial Fibrillation (Omega-3 Comparison Only) [Randomized treatment phase during a mean of 7.4 years]
Includes fatal and non-fatal events.
- Number of Participants With Event: Other Arrhythmia (Omega-3 Comparison Only) [Randomized treatment phase during a mean of 7.4 years]
Includes fatal and non-fatal events, excludes atrial fibrillation.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Males or females with type 1 or type 2 diabetes mellitus.
-
Aged ≥ 40 years.
-
No previous history of vascular disease.
-
No clear contra-indication to aspirin.
-
No other predominant life-threatening medical problem.
Exclusion Criteria:
-
Definite history of myocardial infarction, stroke or arterial revascularisation procedure.
-
Currently prescribed aspirin, warfarin or any other blood thinning medication.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Trial Service Unit, NDPH, University of Oxford | Oxford | United Kingdom | OX3 7LF |
Sponsors and Collaborators
- University of Oxford
- British Heart Foundation
- Bayer
- Medical Research Council
- Solvay Pharmaceuticals
- Abbott
- Mylan
Investigators
- Principal Investigator: Jane M Armitage, BSc, MBBS, MRCP, FFPH, Clinical Trial Service Unit, NDPH, University of Oxford
Study Documents (Full-Text)
More Information
Additional Information:
- The study website for information about ASCEND: A Study of Cardiovascular Events iN Diabetes
- Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus (NEJM 2018)
- Effects of n-3 Fatty Acid Supplements in Diabetes Mellitus (NEJM 2018)
Publications
None provided.Responsible Party:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00135226
Other Study ID Numbers:
- CTSUASCEND1
- 60635500
First Posted:
Aug 25, 2005
Last Update Posted:
Jun 23, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by University of Oxford
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were randomized between June 2005 through July 2011. Follow-up continued until March 2018. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Aspirin + Omega-3 Ethyl Esters | Aspirin + Placebo Omega-3 Ethyl Esters | Placebo Aspirin + Omega-3 Ethyl Esters | Placebo Aspirin + Placebo Omega-3 Ethyl Esters |
|---|---|---|---|---|
| Arm/Group Description | Participants receive 100mg of aspirin once daily and 1g of omega-3 ethyl esters once daily. Aspirin Omega-3 ethyl esters | Participants receive 100mg of aspirin once daily and placebo omega-3 ethyl esters once daily. Aspirin Placebo omega-3 ethyl esters | Participants receive placebo aspirin once daily and 1g of omega-3 ethyl esters once daily. Placebo aspirin Omega-3 ethyl esters | Participants receive placebo aspirin once daily and placebo omega-3 ethyl esters once daily. Placebo aspirin Placebo omega-3 ethyl esters |
| Period Title: Overall Study | ||||
| STARTED | 3870 | 3870 | 3870 | 3870 |
| COMPLETED | 3836 | 3835 | 3836 | 3834 |
| NOT COMPLETED | 34 | 35 | 34 | 36 |
Baseline Characteristics
| Arm/Group Title | Aspirin + Omega-3 | Aspirin + Placebo Omega-3 | Placebo Aspirin + Omega-3 | Placebo Aspirin + Placebo Omega-3 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants receive 100mg of aspirin once daily and 1g of omega-3 ethyl esters once daily. | Participants receive 100mg of aspirin once daily and placebo omega-3 ethyl esters once daily. | Participants receive placebo aspirin once daily and 1g of omega-3 ethyl esters once daily. | Participants receive placebo aspirin once daily and placebo omega-3 ethyl esters once daily. | Total of all reporting groups |
| Overall Participants | 3870 | 3870 | 3870 | 3870 | 15480 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
2257
58.3%
|
2259
58.4%
|
2257
58.3%
|
2261
58.4%
|
9034
58.4%
|
| >=65 years |
1613
41.7%
|
1611
41.6%
|
1613
41.7%
|
1609
41.6%
|
6446
41.6%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
63.2
(9.3)
|
63.2
(9.1)
|
63.3
(9.2)
|
63.3
(9.2)
|
63.3
(9.2)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
1448
37.4%
|
1449
37.4%
|
1450
37.5%
|
1449
37.4%
|
5796
37.4%
|
| Male |
2422
62.6%
|
2421
62.6%
|
2420
62.5%
|
2421
62.6%
|
9684
62.6%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||
| White |
3733
96.5%
|
3734
96.5%
|
3734
96.5%
|
3734
96.5%
|
14935
96.5%
|
| Indian/Pakistani/Bangladeshi |
46
1.2%
|
45
1.2%
|
46
1.2%
|
47
1.2%
|
184
1.2%
|
| African/Caribbean |
34
0.9%
|
36
0.9%
|
36
0.9%
|
34
0.9%
|
140
0.9%
|
| Other/unknown |
57
1.5%
|
55
1.4%
|
54
1.4%
|
55
1.4%
|
221
1.4%
|
| Region of Enrollment (participants) [Number] | |||||
| United Kingdom |
3870
100%
|
3870
100%
|
3870
100%
|
3870
100%
|
15480
100%
|
| Body-mass index (kg/m²) (Count of Participants) | |||||
| <25 |
522
13.5%
|
558
14.4%
|
607
15.7%
|
562
14.5%
|
2249
14.5%
|
| ≥25 to <30 |
1356
35%
|
1397
36.1%
|
1415
36.6%
|
1361
35.2%
|
5529
35.7%
|
| ≥30 |
1863
48.1%
|
1802
46.6%
|
1721
44.5%
|
1815
46.9%
|
7201
46.5%
|
| Unknown |
129
3.3%
|
113
2.9%
|
127
3.3%
|
132
3.4%
|
501
3.2%
|
| Body-mass index (mean) (kg/m²) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [kg/m²] |
30.9
(6.3)
|
30.8
(6.2)
|
30.5
(6.3)
|
30.7
(6.3)
|
30.7
(6.3)
|
| Smoking status (Count of Participants) | |||||
| Current smoker |
319
8.2%
|
320
8.3%
|
320
8.3%
|
320
8.3%
|
1279
8.3%
|
| Ex-smoker |
1764
45.6%
|
1762
45.5%
|
1763
45.6%
|
1762
45.5%
|
7051
45.5%
|
| Never smoked |
1745
45.1%
|
1744
45.1%
|
1744
45.1%
|
1744
45.1%
|
6977
45.1%
|
| Unknown |
42
1.1%
|
44
1.1%
|
43
1.1%
|
44
1.1%
|
173
1.1%
|
| Treated hypertension (Count of Participants) | |||||
| Yes |
2384
61.6%
|
2382
61.6%
|
2384
61.6%
|
2383
61.6%
|
9533
61.6%
|
| No |
1459
37.7%
|
1460
37.7%
|
1458
37.7%
|
1458
37.7%
|
5835
37.7%
|
| Unknown |
27
0.7%
|
28
0.7%
|
28
0.7%
|
29
0.7%
|
112
0.7%
|
| Aspirin use prior to screening (Count of Participants) | |||||
| Yes |
1373
35.5%
|
1367
35.3%
|
1371
35.4%
|
1397
36.1%
|
5508
35.6%
|
| No |
2497
64.5%
|
2503
64.7%
|
2499
64.6%
|
2473
63.9%
|
9972
64.4%
|
| Type of diabetes (Count of Participants) | |||||
| Type 1 |
226
5.8%
|
232
6%
|
234
6%
|
219
5.7%
|
911
5.9%
|
| Type 2 |
3644
94.2%
|
3638
94%
|
3636
94%
|
3651
94.3%
|
14569
94.1%
|
| Duration of diabetes (years) (Count of Participants) | |||||
| <6 yr |
2172
56.1%
|
2165
55.9%
|
2160
55.8%
|
2162
55.9%
|
8659
55.9%
|
| ≥6 <13 yr |
1484
38.3%
|
1492
38.6%
|
1496
38.7%
|
1493
38.6%
|
5965
38.5%
|
| ≥13 yr |
214
5.5%
|
213
5.5%
|
214
5.5%
|
215
5.6%
|
856
5.5%
|
| Duration of diabetes (years) (years) [Median (Inter-Quartile Range) ] | |||||
| Median (Inter-Quartile Range) [years] |
7
|
7
|
7
|
7
|
7
|
| Systolic blood pressure (mmHg) (Count of Participants) | |||||
| <130 mmHg |
849
21.9%
|
845
21.8%
|
846
21.9%
|
854
22.1%
|
3394
21.9%
|
| ≥130 to <140 mmHg |
764
19.7%
|
786
20.3%
|
783
20.2%
|
758
19.6%
|
3091
20%
|
| ≥140 mmHg |
1140
29.5%
|
1123
29%
|
1139
29.4%
|
1153
29.8%
|
4555
29.4%
|
| Unknown |
1117
28.9%
|
1116
28.8%
|
1102
28.5%
|
1105
28.6%
|
4440
28.7%
|
| Systolic blood pressure (mean) (mmHg) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [mmHg] |
136.1
(15.4)
|
136.1
(15.0)
|
136.2
(15.3)
|
136.2
(15.2)
|
136.2
(15.3)
|
| Vascular risk score (Count of Participants) | |||||
| Low (<5%) |
1567
40.5%
|
1561
40.3%
|
1577
40.7%
|
1559
40.3%
|
6264
40.5%
|
| Moderate (≥5%, <10%) |
1635
42.2%
|
1659
42.9%
|
1634
42.2%
|
1620
41.9%
|
6548
42.3%
|
| High (≥10%) |
668
17.3%
|
650
16.8%
|
659
17%
|
691
17.9%
|
2668
17.2%
|
Outcome Measures
| Title | Number of Participants With First Occurrence of Any Serious Vascular Event (SVE) |
|---|---|
| Description | The primary efficacy assessments involve intention-to-treat comparisons among all randomized participants of allocation to aspirin versus placebo and, separately, of omega-3 fatty acids versus placebo on the first occurrence of any "Serious Vascular Event" (SVE), defined as: non-fatal myocardial infarction; or non-fatal stroke (excluding confirmed intracranial hemorrhage) or TIA; or vascular death excluding confirmed intracranial hemorrhage (defined as International Classification of Diseases 10th revision [ICD-10] I00-52 or I63-99, i.e. excluding subarachnoid hemorrhage [I60], intracerebral hemorrhage [I61], and other non-traumatic intracranial hemorrhage [I62]). |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
658
17%
|
743
19.2%
|
689
17.8%
|
712
18.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.01 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.88 | |
| Confidence Interval |
(2-Sided) 95% 0.79 to 0.97 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.55 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.97 | |
| Confidence Interval |
(2-Sided) 95% 0.87 to 1.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only) |
|---|---|
| Description | The primary safety assessments involve intention-to-treat comparisons among all randomized patients of allocation to aspirin versus placebo on the first occurrence of "any major bleed", defined as: any confirmed intracranial hemorrhage (including intracerebral, subarachnoid, subdural or any other intracranial hemorrhage); or sight-threatening eye bleeding; or any other serious bleeding episode. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin |
|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm |
| Measure Participants | 7740 | 7740 |
| Count of Participants [Participants] |
314
8.1%
|
245
6.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 1.29 | |
| Confidence Interval |
(2-Sided) 95% 1.09 to 1.52 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Combined End-point of Serious Vascular Events (SVEs) or Revascularizations |
|---|---|
| Description | Secondary efficacy assessments involve intention-to-treat comparisons among all randomized participants of allocation to aspirin versus placebo and, separately, of omega-3 versus placebo on the first occurrence of the expanded vascular endpoint of "SVE or revascularization" (including coronary and non-coronary revascularizations). |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| A single participant may have had multiple events. |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
833
21.5%
|
936
24.2%
|
882
22.8%
|
887
22.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.88 | |
| Confidence Interval |
(2-Sided) 95% 0.80 to 0.97 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 1.00 | |
| Confidence Interval |
(2-Sided) 95% 0.91 to 1.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Any Incident Gastrointestinal (GI) Tract Cancer (Aspirin Comparison Only) |
|---|---|
| Description | Secondary efficacy assessments of aspirin involve intention-to-treat comparisons during the scheduled treatment period among all randomized participants on the first occurrence of: Any incident gastrointestinal (GI) tract cancer (i.e. any GI cancer excluding pancreas and hepatobiliary), overall and after exclusion of the first three years of follow-up. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants taking aspirin |
| Arm/Group Title | Aspirin | Placebo Aspirin |
|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm |
| Measure Participants | 7740 | 7740 |
| Count of Participants [Participants] |
157
4.1%
|
158
4.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.99 | |
| Confidence Interval |
(2-Sided) 95% 0.80 to 1.24 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Fatal Event: All-cause Mortality |
|---|---|
| Description | 'All-cause mortality' includes all recorded deaths. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
748
19.3%
|
792
20.5%
|
752
19.4%
|
788
20.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.94 | |
| Confidence Interval |
(2-Sided) 95% 0.85 to 1.04 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio |
| Estimated Value | 0.95 | |
| Confidence Interval |
(2-Sided) 95% 0.86 to 1.05 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Fatal Event: Coronary |
|---|---|
| Description | Fatal 'Coronary' events include deaths from: Acute MI and other CHD (unspecified Acute ischaemic heart disease; Atherosclerotic heart disease; Ischaemic cardiomyopathy; unspecified Chronic ischaemic heart disease). |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
105
2.7%
|
122
3.2%
|
100
2.6%
|
127
3.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.86 | |
| Confidence Interval |
(2-Sided) 95% 0.66 to 1.12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 0.79 | |
| Confidence Interval |
(2-Sided) 95% 0.61 to 1.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Fatal Event: All Stroke |
|---|---|
| Description | Fatal 'All stroke' events include deaths from: Haemorrhagic stroke (Intracerebral haemorrhage; Subarachnoid haemorrhage); Non-haemorrhagic stroke (Cerebral infarction; Stroke not specified as haemorrhage or infarction). |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
38
1%
|
34
0.9%
|
35
0.9%
|
37
1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 1.12 | |
| Confidence Interval |
(2-Sided) 95% 0.7 to 1.77 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.94 | |
| Confidence Interval |
(2-Sided) 95% 0.59 to 1.50 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Fatal Event: Other Vascular |
|---|---|
| Description | Fatal 'Other vascular' events include deaths from: Heart failure (excluding ischaemic cardiomyopathy); Other vascular death (excluding stroke; and Cardiac death (excluding CHD). |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
67
1.7%
|
70
1.8%
|
61
1.6%
|
76
2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.96 | |
| Confidence Interval |
(2-Sided) 95% 0.68 to 1.34 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.80 | |
| Confidence Interval |
(2-Sided) 95% 0.57 to 1.12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Fatal Event: Cancer |
|---|---|
| Description | Fatal 'Cancer' events include any death attributed to cancer. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
309
8%
|
315
8.1%
|
305
7.9%
|
319
8.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.98 | |
| Confidence Interval |
(2-Sided) 95% 0.84 to 1.15 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 0.95 | |
| Confidence Interval |
(2-Sided) 95% 0.82 to 1.12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Fatal Event: Respiratory |
|---|---|
| Description | Fatal 'Respiratory' events include any death attributed to respiratory causes. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
82
2.1%
|
69
1.8%
|
73
1.9%
|
78
2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 1.19 | |
| Confidence Interval |
(2-Sided) 95% 0.86 to 1.63 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.93 | |
| Confidence Interval |
(2-Sided) 95% 0.68 to 1.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Fatal Event: Other Medical |
|---|---|
| Description | Fatal 'Other medical' events include deaths from: Non-vascular medical causes (excluding cancer and respiratory, including Fatal GI bleed or perforation); and deaths from Renal disease and Diabetes. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
126
3.3%
|
157
4.1%
|
158
4.1%
|
125
3.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.80 | |
| Confidence Interval |
(2-Sided) 95% 0.64 to 1.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 1.26 | |
| Confidence Interval |
(2-Sided) 95% 1.00 to 1.59 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Fatal Event: External Cause |
|---|---|
| Description | Fatal 'External cause' events include deaths from: Injury; Fracture; Self harm; and Medical and surgical complications |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
18
0.5%
|
21
0.5%
|
17
0.4%
|
22
0.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.86 | |
| Confidence Interval |
(2-Sided) 95% 0.46 to 1.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 0.77 | |
| Confidence Interval |
(2-Sided) 95% 0.41 to 1.45 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Fatal Event: Unknown Cause |
|---|---|
| Description | Any death for which the cause is not known. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
3
0.1%
|
4
0.1%
|
3
0.1%
|
4
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.75 | |
| Confidence Interval |
(2-Sided) 95% 0.17 to 3.30 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.75 | |
| Confidence Interval |
(2-Sided) 95% 0.17 to 3.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Event: Any Cancer |
|---|---|
| Description | Incidence of fatal or non-fatal cancers. Any cancer excludes non-fatal non-melanoma skin cancer and non-fatal recurrence of a cancer that had occurred before randomization. A single participant may have had multiple cancers. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
897
23.2%
|
887
22.9%
|
894
23.1%
|
890
23%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 1.01 | |
| Confidence Interval |
(2-Sided) 95% 0.92 to 1.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio |
| Estimated Value | 1.00 | |
| Confidence Interval |
(2-Sided) 95% 0.91 to 1.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Event: Other Gastrointestinal Cancer (Aspirin Comparison Only) |
|---|---|
| Description | Includes fatal and non-fatal cancers. Excludes cancers reported in the gastrointestinal tract category (see secondary outcome measure #4), and includes hepatobiliary and pancreatic cancers. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin |
|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm |
| Measure Participants | 7740 | 7740 |
| Count of Participants [Participants] |
87
2.2%
|
82
2.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 1.06 | |
| Confidence Interval |
(2-Sided) 95% 0.78 to 1.43 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Event: Respiratory Cancer |
|---|---|
| Description | Includes fatal and non-fatal cancers. Includes lung and larynx cancer. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
101
2.6%
|
103
2.7%
|
104
2.7%
|
100
2.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 0.98 | |
| Confidence Interval |
(2-Sided) 95% 0.74 to 1.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 1.04 | |
| Confidence Interval |
(2-Sided) 95% 0.79 to 1.37 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Event: Genitourinary Cancer |
|---|---|
| Description | Includes fatal and non-fatal renal, bladder, prostate, gynaecological and other GU cancers |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
332
8.6%
|
294
7.6%
|
323
8.3%
|
303
7.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 1.13 | |
| Confidence Interval |
(2-Sided) 95% 0.97 to 1.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 1.07 | |
| Confidence Interval |
(2-Sided) 95% 0.91 to 1.25 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Event: Hematological Cancer |
|---|---|
| Description | Includes fatal and non-fatal cancers. Includes leukaemia and lymphoma. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
88
2.3%
|
86
2.2%
|
94
2.4%
|
80
2.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 1.02 | |
| Confidence Interval |
(2-Sided) 95% 0.76 to 1.38 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 1.17 | |
| Confidence Interval |
(2-Sided) 95% 0.87 to 1.58 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Event: Breast Cancer |
|---|---|
| Description | Includes fatal and non-fatal cancers. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
97
2.5%
|
96
2.5%
|
103
2.7%
|
90
2.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 1.01 | |
| Confidence Interval |
(2-Sided) 95% 0.76 to 1.34 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 1.14 | |
| Confidence Interval |
(2-Sided) 95% 0.86 to 1.52 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Event: Melanoma |
|---|---|
| Description | Includes fatal and non-fatal melanomas. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
50
1.3%
|
59
1.5%
|
55
1.4%
|
54
1.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.85 | |
| Confidence Interval |
(2-Sided) 95% 0.58 to 1.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 1.02 | |
| Confidence Interval |
(2-Sided) 95% 0.70 to 1.48 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Event: Other Cancer |
|---|---|
| Description | Includes fatal and non-fatal cancers not included elsewhere (where the type of cancer is known). |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
25
0.6%
|
30
0.8%
|
23
0.6%
|
32
0.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.83 | |
| Confidence Interval |
(2-Sided) 95% 0.49 to 1.41 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.72 | |
| Confidence Interval |
(2-Sided) 95% 0.42 to 1.22 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Event: Unspecified Cancer |
|---|---|
| Description | Includes fatal and non-fatal cancers of unknown type. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 |
|---|---|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 | 7740 | 7740 |
| Count of Participants [Participants] |
26
0.7%
|
31
0.8%
|
25
0.6%
|
32
0.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.84 | |
| Confidence Interval |
(2-Sided) 95% 0.50 to 1.41 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega-3, Placebo Omega-3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.78 | |
| Confidence Interval |
(2-Sided) 95% 0.46 to 1.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Event: Atrial Fibrillation (Omega-3 Comparison Only) |
|---|---|
| Description | Includes fatal and non-fatal events. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Omega-3 | Placebo Omega-3 |
|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 |
| Count of Participants [Participants] |
166
4.3%
|
135
3.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 1.23 | |
| Confidence Interval |
(2-Sided) 95% 0.98 to 1.54 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Event: Other Arrhythmia (Omega-3 Comparison Only) |
|---|---|
| Description | Includes fatal and non-fatal events, excludes atrial fibrillation. |
| Time Frame | Randomized treatment phase during a mean of 7.4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Omega-3 | Placebo Omega-3 |
|---|---|---|
| Arm/Group Description | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
| Measure Participants | 7740 | 7740 |
| Count of Participants [Participants] |
83
2.1%
|
99
2.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aspirin, Placebo Aspirin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 0.84 | |
| Confidence Interval |
(2-Sided) 95% 0.63 to 1.12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Randomized treatment phase during a mean of 7.4 years | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report. | |||||||
| Arm/Group Title | Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 | ||||
| Arm/Group Description | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm | ||||
All Cause Mortality |
||||||||
| Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 748/7740 (9.7%) | 792/7740 (10.2%) | 752/7740 (9.7%) | 788/7740 (10.2%) | ||||
Serious Adverse Events |
||||||||
| Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5264/7740 (68%) | 5321/7740 (68.7%) | 5344/7740 (69%) | 5241/7740 (67.7%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Blood and lymphatic system disorders | 184/7740 (2.4%) | 145/7740 (1.9%) | 156/7740 (2%) | 173/7740 (2.2%) | ||||
| Cardiac disorders | ||||||||
| Cardiac disorders | 784/7740 (10.1%) | 824/7740 (10.6%) | 812/7740 (10.5%) | 796/7740 (10.3%) | ||||
| Congenital, familial and genetic disorders | ||||||||
| Congenital, familial and genetic disorders | 5/7740 (0.1%) | 4/7740 (0.1%) | 6/7740 (0.1%) | 3/7740 (0%) | ||||
| Ear and labyrinth disorders | ||||||||
| Ear and labyrinth disorders | 44/7740 (0.6%) | 15/7740 (0.2%) | 23/7740 (0.3%) | 36/7740 (0.5%) | ||||
| Endocrine disorders | ||||||||
| Endocrine disorders | 21/7740 (0.3%) | 21/7740 (0.3%) | 24/7740 (0.3%) | 18/7740 (0.2%) | ||||
| Eye disorders | ||||||||
| Eye disorders | 511/7740 (6.6%) | 457/7740 (5.9%) | 486/7740 (6.3%) | 482/7740 (6.2%) | ||||
| Gastrointestinal disorders | ||||||||
| Gastrointestinal disorders | 664/7740 (8.6%) | 635/7740 (8.2%) | 671/7740 (8.7%) | 628/7740 (8.1%) | ||||
| General disorders | ||||||||
| General disorders and administration site conditions | 240/7740 (3.1%) | 231/7740 (3%) | 247/7740 (3.2%) | 224/7740 (2.9%) | ||||
| Hepatobiliary disorders | ||||||||
| Hepatobiliary disorders | 112/7740 (1.4%) | 149/7740 (1.9%) | 134/7740 (1.7%) | 127/7740 (1.6%) | ||||
| Immune system disorders | ||||||||
| Immune system disorders | 27/7740 (0.3%) | 19/7740 (0.2%) | 16/7740 (0.2%) | 30/7740 (0.4%) | ||||
| Infections and infestations | ||||||||
| Infections and infestations | 859/7740 (11.1%) | 804/7740 (10.4%) | 847/7740 (10.9%) | 816/7740 (10.5%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Injury, poisoning and procedural complications | 484/7740 (6.3%) | 479/7740 (6.2%) | 488/7740 (6.3%) | 475/7740 (6.1%) | ||||
| Investigations | ||||||||
| Investigations | 906/7740 (11.7%) | 965/7740 (12.5%) | 935/7740 (12.1%) | 936/7740 (12.1%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Metabolism and nutrition disorders | 200/7740 (2.6%) | 176/7740 (2.3%) | 201/7740 (2.6%) | 175/7740 (2.3%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Musculoskeletal and connective tissue disorders | 248/7740 (3.2%) | 256/7740 (3.3%) | 265/7740 (3.4%) | 239/7740 (3.1%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1320/7740 (17.1%) | 1266/7740 (16.4%) | 1294/7740 (16.7%) | 1292/7740 (16.7%) | ||||
| Nervous system disorders | ||||||||
| Nervous system disorders | 724/7740 (9.4%) | 776/7740 (10%) | 741/7740 (9.6%) | 759/7740 (9.8%) | ||||
| Psychiatric disorders | ||||||||
| Psychiatric disorders | 35/7740 (0.5%) | 41/7740 (0.5%) | 36/7740 (0.5%) | 40/7740 (0.5%) | ||||
| Renal and urinary disorders | ||||||||
| Renal and urinary disorders | 381/7740 (4.9%) | 384/7740 (5%) | 387/7740 (5%) | 378/7740 (4.9%) | ||||
| Reproductive system and breast disorders | ||||||||
| Reproductive system and breast disorders | 157/7740 (2%) | 130/7740 (1.7%) | 137/7740 (1.8%) | 150/7740 (1.9%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Respiratory, thoracic and mediastinal disorders | 436/7740 (5.6%) | 351/7740 (4.5%) | 395/7740 (5.1%) | 392/7740 (5.1%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Skin and subcutaneous tissue disorders | 171/7740 (2.2%) | 127/7740 (1.6%) | 131/7740 (1.7%) | 167/7740 (2.2%) | ||||
| Social circumstances | ||||||||
| Social circumstances | 2/7740 (0%) | 2/7740 (0%) | 3/7740 (0%) | 1/7740 (0%) | ||||
| Surgical and medical procedures | ||||||||
| Surgical and medical procedures | 2916/7740 (37.7%) | 2990/7740 (38.6%) | 2990/7740 (38.6%) | 2916/7740 (37.7%) | ||||
| Vascular disorders | ||||||||
| Vascular disorders | 192/7740 (2.5%) | 213/7740 (2.8%) | 194/7740 (2.5%) | 211/7740 (2.7%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Aspirin | Placebo Aspirin | Omega-3 | Placebo Omega-3 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Prof Jane Armitage |
|---|---|
| Organization | Nuffield Department of Population Health |
| Phone | +44 (0)1865 743743 |
| ascend@ndph.ox.ac.uk |
Responsible Party:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00135226
Other Study ID Numbers:
- CTSUASCEND1
- 60635500
First Posted:
Aug 25, 2005
Last Update Posted:
Jun 23, 2021
Last Verified:
Jun 1, 2021