ASCOT-10: Anglo-Scandinavian Cardiac Outcomes Trial: Post Trial Follow-Up Study

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT01499511
• Collaborator: Pfizer (Industry)
• Enrollment: 1,718
• Location: 1
• Actual Duration (Months): 49
• Patients Per Site Per Month: 35.1

Study Details

Study Description

Brief Summary

ASCOT-10 is a follow-up study of surviving participants in the United Kingdom (UK)arm of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) which was conducted between 2000 and 2005.ASCOT's results showed substantial cardiovascular benefit from: 1) the use of a cholesterol lowering drug (atorvastatin) compared to placebo, and 2) the use of a blood-pressure lowering strategy based on amlodipine when compared to a strategy based on atenolol. ASCOT-10 will test the hypothesis that the ASCOT subjects who originally received Atorvastatin and those who received amlodipine based treatment will continue to show a cardiovascular benefit relative to those who did not, even though all the subjects have had access to optimal treatment in the interim.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Diabetes; Death From Cardiovascular Disease; Myocardial Infarction; Stroke

Detailed Description

Study investigators will have access to information about ASCOT patients from their study centre who have died since the end of the ASCOT study in 2005. Of the 8580 ASCOT patients from the United Kingdom, 7300 were flagged with The Information Centre for Health and Social Care at the end of the trial in 2005.This flagging process was re-activated in 2010 so that all deaths and incident cancers relating to these patients are now sent every three months to the ASCOT-10 co-ordinating centre. These results are identified by the ASCOT study number, with all personal data removed. These deceased patient numbers will be communicated to the participating sites so that the trial centre staff will not contact their families.

An attempt will be made to contact all remaining patients from the participating UK ASCOT sites.

Initial contact will be made via the general practitioner (GP) surgery. If the GP can provide up-to-date contact details and feels that it is appropriate to contact the patient, patients will then be sent an introductory letter, a patient information sheet, a consent form and a health questionnaire.

They will be asked to complete a 'tick-box' form given the following options:

1. Willing to complete health questionnaire.

2. Willing for information about health to be given by GP or next of kin.

3. Willing to give information by telephone only.

4. Willing to attend study clinic for a single visit.

5. Not willing to take part.

They will be asked to complete this form, sign, date and return in a pre-paid envelope to their trial centre. This form will be used as the consent form for the questionnaire part of the study.

They will also be asked to complete a simple health questionnaire. This will collect information on any health problems experienced since the end of the ASCOT trial (in particular about heart attacks and strokes/mini-strokes), as well as information on any hospital admissions during this period and current medication. In addition, information about current weight, exercise, alcohol consumption, smoking and general quality of life will be collected. Patients will be asked to return their completed questionnaire, along with their consent/reply form, to their local trial centre.

If the study team have not received a response within four weeks, a further reminder letter will be sent. If no response has been obtained after a further four weeks, a final attempt will be made to contact the patient by letter or telephone call.

10% of the study population from each trial centre, who will be chosen at random, will be invited to attend their trial centre for a single clinic visit. Further informed consent following discussion with member(s) of the study team will be obtained. During the clinic visit the questionnaire will be reviewed and several further measurements will be taken as follows:

• Blood pressure

• Weight

• Pulse wave analysis. (This is a simple, non-invasive test, very much like a blood pressure measurement, that gives us further information on the function of the heart and arteries)

• Blood for creatinine and estimated glomerular filtration rate(eGFR)(tests of kidney function), electrolytes (sodium and potassium), fasting lipids (cholesterol), fasting glucose, glycated haemoglobin (a further test for diabetes) An additional blood test will be taken and plasma stored for the later analysis of chemicals in the blood which might predict cardiovascular risk. Precise details of this further testing are not currently available. However, the plasma will be stored securely and no identifiable data will be present on the samples (i.e. they will be stored anonymously, identified only by the subject's study number).

Every effort will be taken to contact patients who have moved since the ASCOT study closed and for whom no contact details are available. This may be done by health service tracking services, where available, or via Primary Care Trusts (PCTs).

Study Design

• Study Type: Observational
• Actual Enrollment: 1718 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Anglo-Scandinavian Cardiac Outcomes Trial: Post Trial Follow-Up Study
• Actual Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: May 30, 2015
• Actual Study Completion Date: Jan 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
ASCOT participants amlodipine It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.
ASCOT participants atenolol It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Have Died From Cardiovascular Disease Since the End of the ASCOT Study [16 years]

   Number of participants who have died from cardiovascular disease since the end of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Armstudy

2. Number of Participants With Non Fatal Myocardial Infarction [16 years]

   Morbidity of non fatal myocardial infarction after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial with two groups

3. Number of Participants With Non Fatal Stroke/TIA (Transient Ischaemic Attack) [16 years]

   Non fatal stroke and TIA (Transient Ischaemic Attack) morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial

Secondary Outcome Measures

1. Number of Participants Who Have Developed Diabetes Since the End of the ASCOT Trial [16 years]

   Diabetes morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial

2. Number of Participants Who Have Undergone Coronary/Peripheral Re-vascularisation Procedures Since the End of the ASCOT Trial [16 years]

   Number of participants who have undergone coronary/peripheral re-vascularisation procedures since the end of the ASCOT trial, follow up

3. Number of Participants Who Have Required Renal Replacement Therapy (Dialysis or Kidney Transplant) Since the End of the ASCOT Trial [16 years]

   Number of participants who have required renal replacement therapy (dialysis or kidney transplant) since the end of the ASCOT trial, follow up

4. Number of Participants Who Have Experienced a Transient Ischaemic Attack (TIA) Since the End of the ASCOT Trial [16 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Surviving ASCOT participants from the participating UK sites

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	International Centre for Circulatory Health	London		United Kingdom	W2 1LA

Sponsors and Collaborators

• Imperial College London
• Pfizer

Investigators

• Study Director: Judith A Mackay, MBBS PhD MRCP, Imperial College Healthcare NHS Trust
• Principal Investigator: Peter S Sever, MBChB FRCP PhD, Imperial College London
• Principal Investigator: Simon M Thom, MBBS MD FRCP, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

• Dahlöf B, Sever PS, Poulter NR, Wedel H, Beevers DG, Caulfield M, Collins R, Kjeldsen SE, Kristinsson A, McInnes GT, Mehlsen J, Nieminen M, O'Brien E, Ostergren J; ASCOT Investigators. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet. 2005 Sep 10-16;366(9489):895-906.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT01499511
• Other Study ID Numbers: CRO1667; 2010-023875-24
• First Posted: Dec 26, 2011
• Last Update Posted: Dec 3, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Imperial College London: Hypertension; Mortality; Morbidity; Coronary Heart Disease; Stroke; Diabetes
• Additional relevant MeSH terms: Hypertension; Cardiovascular Diseases; Myocardial Infarction; Infarction

Study Results

Participant Flow

Arm/Group Title	ASCOT Participants Amlodipine	ASCOT Participants Atenolol
Arm/Group Description	It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.	It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
Period Title: Overall Study
STARTED	885	833
COMPLETED	884	833
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	ASCOT Participants Amlodipine	ASCOT Participants Atenolol	Total
Arm/Group Description	It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.	It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.	Total of all reporting groups
Overall Participants	885	833	1718
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	85 9.6%	88 10.6%	173 10.1%
>=65 years	800 90.4%	745 89.4%	1545 89.9%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	75	74.5	74.8
Sex: Female, Male (Count of Participants)
Female	739 83.5%	720 86.4%	1459 84.9%
Male	146 16.5%	113 13.6%	259 15.1%
Region of Enrollment (participants) [Number]
United Kingdom	885 100%	833 100%	1718 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Have Died From Cardiovascular Disease Since the End of the ASCOT Study
Description	Number of participants who have died from cardiovascular disease since the end of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Armstudy
Time Frame	16 years

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	ASCOT Participants
Arm/Group Description	Participants from the ASCOT study recruited to the participating ASCOT study centres in the United Kingdom.
Measure Participants	0

2. Primary Outcome

Title	Number of Participants With Non Fatal Myocardial Infarction
Description	Morbidity of non fatal myocardial infarction after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial with two groups
Time Frame	16 years

Outcome Measure Data

Analysis Population Description

13 participants had missing data

Arm/Group Title	ASCOT Participants Amlodipine	ASCOT Participants Atenolol
Arm/Group Description	It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.	It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
Measure Participants	877	828
Count of Participants [Participants]	35 4%	37 4.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASCOT Participants, ASCOT Participants Atenolol
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.624
	Comments
	Method	ANOVA
	Comments

3. Primary Outcome

Title	Number of Participants With Non Fatal Stroke/TIA (Transient Ischaemic Attack)
Description	Non fatal stroke and TIA (Transient Ischaemic Attack) morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial
Time Frame	16 years

Outcome Measure Data

Analysis Population Description

18 participants had missing data

Arm/Group Title	ASCOT Participants Amlodipine	ASCOT Participants Atenolol
Arm/Group Description	It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.	It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
Measure Participants	877	823
Count of Participants [Participants]	29 3.3%	52 6.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASCOT Participants, ASCOT Participants Atenolol
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	ANOVA
	Comments

4. Secondary Outcome

Title	Number of Participants Who Have Developed Diabetes Since the End of the ASCOT Trial
Description	Diabetes morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial
Time Frame	16 years

Outcome Measure Data

Analysis Population Description

22 participants had missing data

Arm/Group Title	ASCOT Participants Amlodipine	ASCOT Participants Atenolol
Arm/Group Description	It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.	It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
Measure Participants	871	825
Count of Participants [Participants]	322 36.4%	325 39%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASCOT Participants, ASCOT Participants Atenolol
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.304
	Comments
	Method	ANOVA
	Comments

5. Secondary Outcome

Title	Number of Participants Who Have Undergone Coronary/Peripheral Re-vascularisation Procedures Since the End of the ASCOT Trial
Description	Number of participants who have undergone coronary/peripheral re-vascularisation procedures since the end of the ASCOT trial, follow up
Time Frame	16 years

Outcome Measure Data

Analysis Population Description

24 participants had missing data

Arm/Group Title	ASCOT Participants Amlodipine	ASCOT Participants Atenolol
Arm/Group Description	It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.	It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
Measure Participants	872	822
Count of Participants [Participants]	39 4.4%	33 4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASCOT Participants, ASCOT Participants Atenolol
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.641
	Comments
	Method	ANOVA
	Comments

6. Secondary Outcome

Title	Number of Participants Who Have Required Renal Replacement Therapy (Dialysis or Kidney Transplant) Since the End of the ASCOT Trial
Description	Number of participants who have required renal replacement therapy (dialysis or kidney transplant) since the end of the ASCOT trial, follow up
Time Frame	16 years

Outcome Measure Data

Analysis Population Description

18 participants had missing data

Arm/Group Title	ASCOT Participants Amlodipine	ASCOT Participants Atenolol
Arm/Group Description	It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.	It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
Measure Participants	874	826
Count of Participants [Participants]	10 1.1%	9 1.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASCOT Participants, ASCOT Participants Atenolol
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.915
	Comments
	Method	ANOVA
	Comments

7. Secondary Outcome

Title	Number of Participants Who Have Experienced a Transient Ischaemic Attack (TIA) Since the End of the ASCOT Trial
Time Frame	16 years

Outcome Measure Data

Analysis Population Description

Combined together with 3. primary outcome, it was not possible to differentiate between data collected for TIAs and Non fatal stroke

Arm/Group Title	ASCOT Participants Amlodipine	ASCOT Participants Atenolol
Arm/Group Description	It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.	It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
Measure Participants	0	0

Adverse Events

Time Frame	16 years
Arm/Group Title	ASCOT Participants Amlodipine		ASCOT Participants Atenolol
Arm/Group Description	Follow up study for amlodipine, no intervention.		Follow up study for atenolol, no intervention.
All Cause Mortality
	ASCOT Participants Amlodipine		ASCOT Participants Atenolol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/885 (0.1%)		0/833 (0%)
Serious Adverse Events
	ASCOT Participants Amlodipine		ASCOT Participants Atenolol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/885 (0.2%)		0/833 (0%)
Cardiac disorders
Ischaemic stroke	1/885 (0.1%)	1	0/833 (0%)	0
Musculoskeletal and connective tissue disorders
Injuries	1/885 (0.1%)	1	0/833 (0%)	0
Other (Not Including Serious) Adverse Events
	ASCOT Participants Amlodipine		ASCOT Participants Atenolol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/885 (0.5%)		1/833 (0.1%)
Cardiac disorders
High blood pressure	1/885 (0.1%)	1	0/833 (0%)	0
Gastrointestinal disorders
Stomach cramps	1/885 (0.1%)	1	0/833 (0%)	0
Nervous system disorders
Collapse	0/885 (0%)	0	1/833 (0.1%)	1
Alcohol dependence withdrawal	1/885 (0.1%)	1	0/833 (0%)	0
Respiratory, thoracic and mediastinal disorders
Bronchiectasis	1/885 (0.1%)	1	0/833 (0%)	0

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.