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

NCT01499511 | Completed Results

• 2 other identifiers: CRO16672010-023875-24
• Study Type: observational
• Target: 1,718
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Diabetes; Death From Cardiovascular Disease; Myocardial Infarction; Stroke

Keywords

Hypertension; Mortality; Morbidity; Coronary Heart Disease; Stroke; Diabetes

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Number of Participants Who Have Developed Diabetes 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

  16 years

• 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 Experienced a Transient Ischaemic Attack (TIA) Since the End of the ASCOT Trial

  16 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Surviving ASCOT participants from the participating UK sites

You may not qualify if:

• None

Sponsors & Collaborators

• Imperial College London: lead
• Pfizer: collaborator

Study Sites (1)

International Centre for Circulatory Health

London, W2 1LA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 16154016 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma to be stored for future measurement of biochemical markers of cardiovascular disease

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Myocardial Infarction; Stroke; Coronary Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Professor Peter Sever
• Organization: Imperial College London

p.sever@imperial.ac.uk

02075941100

Study Officials

• Judith A Mackay, MBBS PhD MRCP

  Imperial College Healthcare NHS Trust

  STUDY DIRECTOR

• Peter S Sever, MBChB FRCP PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Simon M Thom, MBBS MD FRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: December 26, 2011
• Study Start: January 1, 2012
• Primary Completion: May 30, 2015
• Study Completion: January 31, 2016
• Last Updated: December 3, 2019
• Results First Posted: December 3, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)