Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome
Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00435487
Collaborator
(none)
173
8
2
18
21.6
1.2
Study Details
Study Description
Brief Summary
To compare efficacy and safety of dalteparin compared to unfractionated heparin in patients of non ST elevation acute coronary syndromes who are planned to undergo coronary interventions (angioplasty or bypass surgery)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The study was prematurely discontinued on November 30, 2008 due to delay in meeting pre-defined protocol recruitment milestones. There were no safety concerns regarding the study in the decision to terminate the trial.
Study Design
Study Type:
Interventional
Actual Enrollment
:
173 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Phase IV Open Label Comparative Study Of Dalteparin vs Unfractionated Heparin In High Risk Patients Of Non-ST Elevation Acute Coronary Syndromes Intended For Early Invasive Strategy
Study Start Date
:
Jun 1, 2007
Actual Primary Completion Date
:
Dec 1, 2008
Actual Study Completion Date
:
Dec 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A
|
Drug: Dalteparin ( Fragmin)
Dalteparin will be administered at a dose of 120 IU/kg (international units per kilogram) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours.
|
| Active Comparator: B
|
Drug: Unfractionated heparin
Unfractionated heparin will be given intravenously according to a weight-adjusted nomogram (bolus of 60 U/kg [units per kilogram] and initial infusion of 12 U/kg/h [units per kilogram per hour]).
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30 [Baseline to Day 30]
Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) on or before day 30 from baseline. Death: fatal event resulting from any cause. New MI: electrocardiographic (ECG) and or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test.
Secondary Outcome Measures
- Number of Subjects With Stroke [End of hospitalization, Day 30]
Stroke: a sudden, focal neurologic deficit that is not reversible within 24 hours and is not the result of any readily identifiable cause (e.g., tumor or trauma).
- Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization [End of hospitalization, Day 30]
Recurrent angina: angina at rest lasting at least five minutes that was associated with a new ST-segment shift (elevation or depression) of more than 0.1 millivolt (mV), or with T-wave inversions, in two contiguous electrocardiographic leads; angina without electrocardiographic changes that prompted a decision to perform a revascularization procedure; or angina after hospital discharge that resulted in rehospitalization.
- Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days [End of hospitalization, Day 30]
Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) at end of hospitalization and on Day 30. Death: fatal event resulting from any cause. New MI: defined by electrocardiographic and/or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test.
- Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization [End of hospitalization, Day 30]
Abrupt vessel closure and or stent thrombosis: occurrence of vessel closure (no visible antegrade flow of contrast dye occurring after balloon angioplasty) or stent thrombosis determined angiographically.
- Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria [End of hospitalization, Day 30]
Thrombolysis in myocardial infarction (TIMI) major bleeding: at least a 5-grams per deciliter (g/dL) decrease in hemoglobin, at least a 15 percent (%) decrease in hematocrit, or intracranial bleeding. TIMI minor bleeding: associated with gastrointestinal or genitourinary bleeding, with an absolute decrease in hemoglobin of 4 g/dL or more, or decrease in hematocrit of at least 12%.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients more than 18 years
-
Ischemic pain of more than 10 minutes within 24 hours before enrollment
-
At least two of the following three risk factors : Age more than 60 years ( or more than 50 in case of diabetics), Raised cardiac enzyme levels, abnormal ECG findings
Exclusion Criteria:
-
Contraindications to use of anticoagulants
-
Active bleeding or abnormal coagulation tests
-
Ischemic stroke within last 6 months or hemorrhagic stroke
-
Lumbar or spinal puncture within last 48 hours
-
S creatinine levels more than 2
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Hyderabad | Andhra Pradesh | India | 500 034 |
| 2 | Pfizer Investigational Site | Hyderabad | Andra Pradesh | India | 500 001 |
| 3 | Pfizer Investigational Site | Nagpur | Maharashtra | India | 440 012 |
| 4 | Pfizer Investigational Site | Pune | Maharashtra | India | 411 001 |
| 5 | Pfizer Investigational Site | Pune | Maharashtra | India | 411 004 |
| 6 | Pfizer Investigational Site | Ludhiana | Punjab | India | 141 001 |
| 7 | Pfizer Investigational Site | Coimbatore | Tamil Nadu | India | 641 014 |
| 8 | Pfizer Investigational Site | Karnataka | India | 560 034 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00435487
Other Study ID Numbers:
- A6301079
First Posted:
Feb 15, 2007
Last Update Posted:
Oct 17, 2011
Last Verified:
Oct 1, 2011
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects participated in the study between 22 June 2007 and 30 December 2008. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm A: Dalteparin | Arm B: Unfractioned Heparin (UFH) |
|---|---|---|
| Arm/Group Description | 120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. | Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. |
| Period Title: Overall Study | ||
| STARTED | 88 | 86 |
| TREATED | 88 | 83 |
| COMPLETED | 76 | 71 |
| NOT COMPLETED | 12 | 15 |
Baseline Characteristics
| Arm/Group Title | Arm A: Dalteparin | Arm B: Unfractioned Heparin (UFH) | Total |
|---|---|---|---|
| Arm/Group Description | 120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. | Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. | Total of all reporting groups |
| Overall Participants | 88 | 83 | 171 |
| Age, Customized (participants) [Number] | |||
| 18 - 44 years |
6
6.8%
|
5
6%
|
11
6.4%
|
| 45 - 64 years |
36
40.9%
|
40
48.2%
|
76
44.4%
|
| >=65 years |
46
52.3%
|
38
45.8%
|
84
49.1%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
29
33%
|
40
48.2%
|
69
40.4%
|
| Male |
59
67%
|
43
51.8%
|
102
59.6%
|
Outcome Measures
| Title | Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30 |
|---|---|
| Description | Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) on or before day 30 from baseline. Death: fatal event resulting from any cause. New MI: electrocardiographic (ECG) and or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test. |
| Time Frame | Baseline to Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population: all subjects who took study medication for at least 48 hours from baseline and had complete information on the endpoint. |
| Arm/Group Title | Arm A: Dalteparin | Arm B: Unfractioned Heparin (UFH) |
|---|---|---|
| Arm/Group Description | 120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. | Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. |
| Measure Participants | 79 | 78 |
| Death |
2
2.3%
|
4
4.8%
|
| Non-fatal Myocardial Infarction |
2
2.3%
|
1
1.2%
|
| Death or Non-fatal Myocardial Infarction |
4
4.5%
|
5
6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Dalteparin, Arm B: Unfractioned Heparin (UFH) |
|---|---|---|
| Comments | Death after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%). | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportion |
| Estimated Value | -2.60 | |
| Confidence Interval |
() 95% -8.59 to 3.40 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 95% confidence interval (CI) is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Dalteparin, Arm B: Unfractioned Heparin (UFH) |
|---|---|---|
| Comments | Non-fatal Myocardial Infarction after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%). | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportion |
| Estimated Value | 1.25 | |
| Confidence Interval |
() 95% -3.02 to 5.52 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 95% CI is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Dalteparin, Arm B: Unfractioned Heparin (UFH) |
|---|---|---|
| Comments | Death or Non-fatal Myocardial Infarction after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%). | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportion |
| Estimated Value | -1.35 | |
| Confidence Interval |
() 95% -8.62 to 5.93 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 95% CI is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%. | |
| Title | Number of Subjects With Stroke |
|---|---|
| Description | Stroke: a sudden, focal neurologic deficit that is not reversible within 24 hours and is not the result of any readily identifiable cause (e.g., tumor or trauma). |
| Time Frame | End of hospitalization, Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population |
| Arm/Group Title | Arm A: Dalteparin | Arm B: Unfractioned Heparin (UFH) |
|---|---|---|
| Arm/Group Description | 120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. | Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. |
| Measure Participants | 79 | 78 |
| Number [participants] |
1
1.1%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Dalteparin, Arm B: Unfractioned Heparin (UFH) |
|---|---|---|
| Comments | Difference in proportion (Dalteparin-UFH)(%). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.0000 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportion |
| Estimated Value | 1.27 | |
| Confidence Interval |
() 95% -1.20 to 3.73 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 95% CI is for difference in proportion using normal approximation to binomial. | |
| Title | Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization |
|---|---|
| Description | Recurrent angina: angina at rest lasting at least five minutes that was associated with a new ST-segment shift (elevation or depression) of more than 0.1 millivolt (mV), or with T-wave inversions, in two contiguous electrocardiographic leads; angina without electrocardiographic changes that prompted a decision to perform a revascularization procedure; or angina after hospital discharge that resulted in rehospitalization. |
| Time Frame | End of hospitalization, Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population |
| Arm/Group Title | Arm A: Dalteparin | Arm B: Unfractioned Heparin (UFH) |
|---|---|---|
| Arm/Group Description | 120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. | Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. |
| Measure Participants | 79 | 78 |
| Number [participants] |
3
3.4%
|
3
3.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Dalteparin, Arm B: Unfractioned Heparin (UFH) |
|---|---|---|
| Comments | Difference in proportion (Dalteparin-UFH)(%). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.0000 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportion |
| Estimated Value | -0.05 | |
| Confidence Interval |
() 95% -6.05 to 5.95 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 95% CI is for difference in proportion using normal approximation to binomial. | |
| Title | Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days |
|---|---|
| Description | Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) at end of hospitalization and on Day 30. Death: fatal event resulting from any cause. New MI: defined by electrocardiographic and/or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test. |
| Time Frame | End of hospitalization, Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population |
| Arm/Group Title | Arm A: Dalteparin | Arm B: Unfractioned Heparin (UFH) |
|---|---|---|
| Arm/Group Description | 120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. | Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. |
| Measure Participants | 79 | 78 |
| Number [participants] |
3
3.4%
|
3
3.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Dalteparin, Arm B: Unfractioned Heparin (UFH) |
|---|---|---|
| Comments | Difference in proportion (Dalteparin-UFH)(%). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.0000 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportion |
| Estimated Value | -0.05 | |
| Confidence Interval |
() 95% -6.05 to 5.95 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 95% CI is for difference in proportion using normal approximation to binomial. | |
| Title | Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization |
|---|---|
| Description | Abrupt vessel closure and or stent thrombosis: occurrence of vessel closure (no visible antegrade flow of contrast dye occurring after balloon angioplasty) or stent thrombosis determined angiographically. |
| Time Frame | End of hospitalization, Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population |
| Arm/Group Title | Arm A: Dalteparin | Arm B: Unfractioned Heparin (UFH) |
|---|---|---|
| Arm/Group Description | 120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. | Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. |
| Measure Participants | 79 | 78 |
| Number [participants] |
0
0%
|
0
0%
|
| Title | Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria |
|---|---|
| Description | Thrombolysis in myocardial infarction (TIMI) major bleeding: at least a 5-grams per deciliter (g/dL) decrease in hemoglobin, at least a 15 percent (%) decrease in hematocrit, or intracranial bleeding. TIMI minor bleeding: associated with gastrointestinal or genitourinary bleeding, with an absolute decrease in hemoglobin of 4 g/dL or more, or decrease in hematocrit of at least 12%. |
| Time Frame | End of hospitalization, Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population |
| Arm/Group Title | Arm A: Dalteparin | Arm B: Unfractioned Heparin (UFH) |
|---|---|---|
| Arm/Group Description | 120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. | Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. |
| Measure Participants | 79 | 78 |
| Number [participants] |
0
0%
|
0
0%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Arm A: Dalteparin | Arm B: Unfractioned Heparin (UFH) | ||
| Arm/Group Description | 120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. | Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. | ||
All Cause Mortality |
||||
| Arm A: Dalteparin | Arm B: Unfractioned Heparin (UFH) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Arm A: Dalteparin | Arm B: Unfractioned Heparin (UFH) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/88 (4.5%) | 13/83 (15.7%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/88 (0%) | 1/83 (1.2%) | ||
| Cardiac disorders | ||||
| Angina pectoris | 0/88 (0%) | 2/83 (2.4%) | ||
| Angina unstable | 0/88 (0%) | 1/83 (1.2%) | ||
| Cardiac arrest | 2/88 (2.3%) | 1/83 (1.2%) | ||
| Cardiac tamponade | 0/88 (0%) | 1/83 (1.2%) | ||
| Cardiogenic shock | 1/88 (1.1%) | 1/83 (1.2%) | ||
| Ventricular tachycardia | 1/88 (1.1%) | 0/83 (0%) | ||
| Gastrointestinal disorders | ||||
| Gastrointestinal haemorrhage | 0/88 (0%) | 1/83 (1.2%) | ||
| General disorders | ||||
| Chest pain | 0/88 (0%) | 2/83 (2.4%) | ||
| Injury, poisoning and procedural complications | ||||
| Collapse of lung | 0/88 (0%) | 1/83 (1.2%) | ||
| Nervous system disorders | ||||
| Hemiparesis | 1/88 (1.1%) | 0/83 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute pulmonary oedema | 0/88 (0%) | 1/83 (1.2%) | ||
| Acute respiratory failure | 0/88 (0%) | 1/83 (1.2%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Arm A: Dalteparin | Arm B: Unfractioned Heparin (UFH) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 58/88 (65.9%) | 59/83 (71.1%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 4/88 (4.5%) | 5/83 (6%) | ||
| Cardiac disorders | ||||
| Angina pectoris | 4/88 (4.5%) | 1/83 (1.2%) | ||
| Atrial fibrillation | 0/88 (0%) | 1/83 (1.2%) | ||
| Atrial flutter | 0/88 (0%) | 1/83 (1.2%) | ||
| Atrioventricular block second degree | 0/88 (0%) | 1/83 (1.2%) | ||
| Bradycardia | 1/88 (1.1%) | 0/83 (0%) | ||
| Cardiac asthma | 0/88 (0%) | 1/83 (1.2%) | ||
| Left ventricular failure | 0/88 (0%) | 3/83 (3.6%) | ||
| Palpitations | 0/88 (0%) | 1/83 (1.2%) | ||
| Tachycardia | 2/88 (2.3%) | 1/83 (1.2%) | ||
| Ventricular extrasystoles | 1/88 (1.1%) | 1/83 (1.2%) | ||
| Ventricular tachycardia | 1/88 (1.1%) | 0/83 (0%) | ||
| Ear and labyrinth disorders | ||||
| Ear pain | 1/88 (1.1%) | 0/83 (0%) | ||
| Tinnitus | 1/88 (1.1%) | 0/83 (0%) | ||
| Eye disorders | ||||
| Cataract | 1/88 (1.1%) | 1/83 (1.2%) | ||
| Eye pain | 0/88 (0%) | 1/83 (1.2%) | ||
| Pseudophakia | 0/88 (0%) | 1/83 (1.2%) | ||
| Retinopathy hypertensive | 1/88 (1.1%) | 0/83 (0%) | ||
| Vitreous haemorrhage | 0/88 (0%) | 1/83 (1.2%) | ||
| Gastrointestinal disorders | ||||
| Abdominal discomfort | 0/88 (0%) | 1/83 (1.2%) | ||
| Abdominal distension | 0/88 (0%) | 1/83 (1.2%) | ||
| Abdominal pain | 1/88 (1.1%) | 3/83 (3.6%) | ||
| Abdominal pain upper | 1/88 (1.1%) | 0/83 (0%) | ||
| Abdominal tenderness | 0/88 (0%) | 1/83 (1.2%) | ||
| Constipation | 6/88 (6.8%) | 9/83 (10.8%) | ||
| Diarrhoea | 2/88 (2.3%) | 4/83 (4.8%) | ||
| Dyspepsia | 0/88 (0%) | 2/83 (2.4%) | ||
| Gastritis erosive | 0/88 (0%) | 1/83 (1.2%) | ||
| Gastrointestinal haemorrhage | 1/88 (1.1%) | 0/83 (0%) | ||
| Gingival bleeding | 0/88 (0%) | 1/83 (1.2%) | ||
| Haematemesis | 1/88 (1.1%) | 0/83 (0%) | ||
| Mouth haemorrhage | 1/88 (1.1%) | 0/83 (0%) | ||
| Nausea | 3/88 (3.4%) | 6/83 (7.2%) | ||
| Stomatitis | 1/88 (1.1%) | 0/83 (0%) | ||
| Vomiting | 4/88 (4.5%) | 4/83 (4.8%) | ||
| General disorders | ||||
| Asthenia | 1/88 (1.1%) | 2/83 (2.4%) | ||
| Chest pain | 9/88 (10.2%) | 6/83 (7.2%) | ||
| Chills | 1/88 (1.1%) | 1/83 (1.2%) | ||
| Facial pain | 0/88 (0%) | 1/83 (1.2%) | ||
| Oedema | 1/88 (1.1%) | 0/83 (0%) | ||
| Oedema peripheral | 0/88 (0%) | 4/83 (4.8%) | ||
| Pain | 3/88 (3.4%) | 0/83 (0%) | ||
| Puncture site reaction | 0/88 (0%) | 1/83 (1.2%) | ||
| Pyrexia | 13/88 (14.8%) | 9/83 (10.8%) | ||
| Infections and infestations | ||||
| Pneumonia | 1/88 (1.1%) | 0/83 (0%) | ||
| Upper respiratory tract infection | 0/88 (0%) | 1/83 (1.2%) | ||
| Urinary tract infection | 2/88 (2.3%) | 3/83 (3.6%) | ||
| Investigations | ||||
| Blood creatinine increased | 2/88 (2.3%) | 1/83 (1.2%) | ||
| Blood pressure increased | 1/88 (1.1%) | 0/83 (0%) | ||
| ECG signs of myocardial ischaemia | 0/88 (0%) | 2/83 (2.4%) | ||
| Electrocardiogram ST segment depression | 1/88 (1.1%) | 0/83 (0%) | ||
| International normalised ratio increased | 0/88 (0%) | 1/83 (1.2%) | ||
| Platelet count decreased | 1/88 (1.1%) | 0/83 (0%) | ||
| Venous pressure jugular increased | 2/88 (2.3%) | 2/83 (2.4%) | ||
| White blood cell count increased | 2/88 (2.3%) | 0/83 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Acidosis | 2/88 (2.3%) | 1/83 (1.2%) | ||
| Anorexia | 0/88 (0%) | 2/83 (2.4%) | ||
| Hyperglycaemia | 2/88 (2.3%) | 1/83 (1.2%) | ||
| Hyperlipidaemia | 1/88 (1.1%) | 2/83 (2.4%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 2/88 (2.3%) | 5/83 (6%) | ||
| Joint crepitation | 1/88 (1.1%) | 0/83 (0%) | ||
| Muscle spasms | 1/88 (1.1%) | 1/83 (1.2%) | ||
| Musculoskeletal pain | 1/88 (1.1%) | 1/83 (1.2%) | ||
| Musculoskeletal stiffness | 0/88 (0%) | 1/83 (1.2%) | ||
| Myalgia | 1/88 (1.1%) | 1/83 (1.2%) | ||
| Neck pain | 0/88 (0%) | 1/83 (1.2%) | ||
| Pain in extremity | 3/88 (3.4%) | 3/83 (3.6%) | ||
| Sensation of heaviness | 0/88 (0%) | 1/83 (1.2%) | ||
| Nervous system disorders | ||||
| Diabetic neuropathy | 0/88 (0%) | 1/83 (1.2%) | ||
| Dizziness | 3/88 (3.4%) | 2/83 (2.4%) | ||
| Headache | 4/88 (4.5%) | 10/83 (12%) | ||
| Syncope | 0/88 (0%) | 1/83 (1.2%) | ||
| Psychiatric disorders | ||||
| Abnormal behaviour | 1/88 (1.1%) | 0/83 (0%) | ||
| Anxiety | 4/88 (4.5%) | 4/83 (4.8%) | ||
| Insomnia | 1/88 (1.1%) | 1/83 (1.2%) | ||
| Psychotic disorder | 1/88 (1.1%) | 0/83 (0%) | ||
| Sleep disorder | 0/88 (0%) | 2/83 (2.4%) | ||
| Renal and urinary disorders | ||||
| Diabetic nephropathy | 1/88 (1.1%) | 0/83 (0%) | ||
| Dysuria | 1/88 (1.1%) | 1/83 (1.2%) | ||
| Haematuria | 1/88 (1.1%) | 0/83 (0%) | ||
| Renal artery stenosis | 0/88 (0%) | 1/83 (1.2%) | ||
| Renal disorder | 1/88 (1.1%) | 0/83 (0%) | ||
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 1/88 (1.1%) | 0/83 (0%) | ||
| Prostatomegaly | 1/88 (1.1%) | 1/83 (1.2%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Choking sensation | 2/88 (2.3%) | 1/83 (1.2%) | ||
| Cough | 6/88 (6.8%) | 8/83 (9.6%) | ||
| Dyspnoea | 6/88 (6.8%) | 4/83 (4.8%) | ||
| Dyspnoea exertional | 0/88 (0%) | 1/83 (1.2%) | ||
| Haemoptysis | 1/88 (1.1%) | 0/83 (0%) | ||
| Hiccups | 0/88 (0%) | 1/83 (1.2%) | ||
| Oropharyngeal pain | 1/88 (1.1%) | 0/83 (0%) | ||
| Orthopnoea | 0/88 (0%) | 2/83 (2.4%) | ||
| Painful respiration | 0/88 (0%) | 1/83 (1.2%) | ||
| Productive cough | 1/88 (1.1%) | 4/83 (4.8%) | ||
| Rales | 2/88 (2.3%) | 1/83 (1.2%) | ||
| Respiratory distress | 1/88 (1.1%) | 0/83 (0%) | ||
| Sputum discoloured | 1/88 (1.1%) | 0/83 (0%) | ||
| Tachypnoea | 0/88 (0%) | 1/83 (1.2%) | ||
| Wheezing | 1/88 (1.1%) | 0/83 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Blister | 1/88 (1.1%) | 0/83 (0%) | ||
| Ecchymosis | 0/88 (0%) | 1/83 (1.2%) | ||
| Intertrigo | 0/88 (0%) | 1/83 (1.2%) | ||
| Rash | 0/88 (0%) | 1/83 (1.2%) | ||
| Skin discolouration | 1/88 (1.1%) | 0/83 (0%) | ||
| Skin exfoliation | 0/88 (0%) | 1/83 (1.2%) | ||
| Vascular disorders | ||||
| Arteriosclerosis | 0/88 (0%) | 1/83 (1.2%) | ||
| Haematoma | 1/88 (1.1%) | 1/83 (1.2%) | ||
| Hypertension | 1/88 (1.1%) | 1/83 (1.2%) | ||
| Hypotension | 0/88 (0%) | 3/83 (3.6%) | ||
| Ischaemia | 0/88 (0%) | 2/83 (2.4%) | ||
| Peripheral vascular disorder | 0/88 (0%) | 1/83 (1.2%) | ||
| Thrombophlebitis | 0/88 (0%) | 1/83 (1.2%) | ||
Limitations/Caveats
This study was terminated due to insufficient recruitment of subjects.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.govCallCenter@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00435487
Other Study ID Numbers:
- A6301079
First Posted:
Feb 15, 2007
Last Update Posted:
Oct 17, 2011
Last Verified:
Oct 1, 2011