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

This study is not yet open for participant recruitment.
Verified December 2011 by Imperial College London
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01499511
First received: February 7, 2011
Last updated: December 22, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Hypertension
Diabetes
Death From Cardiovascular Disease
Myocardial Infarction
Stroke

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Anglo-Scandinavian Cardiac Outcomes Trial: Post Trial Follow-Up Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Number of participants who have died from cardiovascular disease and the number who have suffered a non-fatal myocardial infarction (MI) and/or non-fatal stroke since the end of the ASCOT study [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants who have developed diabetes since the end of the ASCOT trial [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Number of participants who have undergone coronary/peripheral re-vascularisation procedures since the end of the ASCOT trial [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Number of participants who have required renal replacement therapy (dialysis or kidney transplant) since the end of the ASCOT trial [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Number of participants who have experienced a transient ischaemic attack since the end of the ASCOT trial [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 5450
Study Start Date: January 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
ASCOT participants
Participants from the ASCOT study recruited to the participating ASCOT study centres in the United Kingdom.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Surviving ASCOT participants from the participating UK sites

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499511

Contacts
Contact: Judith A Mackay, MBBS PhD MRCP +442075941395 judith.mackay@imperial.nhs.uk
Contact: Peter S Sever, MbChB FRCP PhD +442075941099 p.sever@imperial.ac.uk

Locations
United Kingdom
International Centre for Circulatory Health Not yet recruiting
London, United Kingdom, W2 1LA
Contact: Judith A Mackay, MBBS PhD MRCP     +442075941395     judith.mackay@imperial.nhs.uk    
Contact: Peter S Sever, MBCHB PhD FRCP     +442075941099     p.sever@imperial.ac.uk    
Principal Investigator: Judith A Mackay, MBBS PhD MRCP            
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
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01499511     History of Changes
Other Study ID Numbers: CRO1667, 2010-023875-24
Study First Received: February 7, 2011
Last Updated: December 22, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
Hypertension
Mortality
Morbidity
 Coronary Heart Disease
Stroke
Diabetes

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Hypertension
Infarction
Myocardial Infarction
Stroke
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
 Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013