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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Stroke; Hypertension; Diabetes; Death From Cardiovascular Disease

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 Type: Observational
• Enrollment (Actual): 1718

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W2 1LA
    • International Centre for Circulatory Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who participated in the Anglo-Scandinavian Cardiac Outcomes Trial in the UK

Description

Inclusion Criteria:

• Surviving ASCOT participants from the participating UK sites

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Have Died From Cardiovascular Disease Since the End of the ASCOT Study	Number of participants who have died from cardiovascular disease since the end of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Armstudy	16 years
Number of Participants With Non Fatal Myocardial Infarction	Morbidity of non fatal myocardial infarction after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial with two groups	16 years
Number of Participants With Non Fatal Stroke/TIA (Transient Ischaemic Attack)	Non fatal stroke and TIA (Transient Ischaemic Attack) morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial	16 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Have Developed Diabetes Since the End of the ASCOT Trial	Diabetes morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial	16 years
Number of Participants Who Have Undergone Coronary/Peripheral Re-vascularisation Procedures Since the End of the ASCOT Trial	Number of participants who have undergone coronary/peripheral re-vascularisation procedures since the end of the ASCOT trial, follow up	16 years
Number of Participants Who Have Required Renal Replacement Therapy (Dialysis or Kidney Transplant) Since the End of the ASCOT Trial	Number of participants who have required renal replacement therapy (dialysis or kidney transplant) since the end of the ASCOT trial, follow up	16 years
Number of Participants Who Have Experienced a Transient Ischaemic Attack (TIA) Since the End of the ASCOT Trial		16 years

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: 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

Publications and helpful links

General Publications

• Dahlof 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. doi: 10.1016/S0140-6736(05)67185-1.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): May 30, 2015
• Study Completion (Actual): January 31, 2016

Study Registration Dates

• First Submitted: February 7, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Diabetes; Stroke; Hypertension; Morbidity; Mortality; Coronary Heart Disease
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Hypertension; Cardiovascular Diseases
• Other Study ID Numbers: CRO1667; 2010-023875-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No