Clinical trial NCT01499511: Anglo-Scandinavian Cardiac Outcomes Trial: Post Trial Follow-Up Study
Official title: Anglo-Scandinavian Cardiac Outcomes Trial: Post Trial Follow-Up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Diabetes
Death From Cardiovascular Disease
Myocardial Infarction
Stroke
Keywords: Hypertension
Mortality
Morbidity
Coronary Heart Disease
Stroke
Diabetes
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-12-26
Enrollment: 1718
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who participated in the Anglo-Scandinavian Cardiac Outcomes Trial in the UK

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.

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).

Eligibility criteria: Inclusion Criteria:

* Surviving ASCOT participants from the participating UK sites

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants Who Have Died From Cardiovascular Disease Since the End of the ASCOT Study
timeFrame: 16 years
measure: Number of Participants With Non Fatal Myocardial Infarction
timeFrame: 16 years
measure: Number of Participants With Non Fatal Stroke/TIA (Transient Ischaemic Attack)
timeFrame: 16 years
Secondary outcomes:
measure: Number of Participants Who Have Developed Diabetes Since the End of the ASCOT Trial
timeFrame: 16 years
measure: Number of Participants Who Have Undergone Coronary/Peripheral Re-vascularisation Procedures Since the End of the ASCOT Trial
timeFrame: 16 years
measure: Number of Participants Who Have Required Renal Replacement Therapy (Dialysis or Kidney Transplant) Since the End of the ASCOT Trial
timeFrame: 16 years
measure: Number of Participants Who Have Experienced a Transient Ischaemic Attack (TIA) Since the End of the ASCOT Trial
timeFrame: 16 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: International Centre for Circulatory Health
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Judith A Mackay, MBBS PhD MRCP
role: STUDY_DIRECTOR
affiliation: Imperial College London
name: Peter S Sever, MBChB FRCP PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Simon M Thom, MBBS MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.