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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Imperial College London.
Recruitment status was:  Not yet recruiting
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
  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:


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   (Adult, Senior)
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499511

Locations
United Kingdom
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
  More Information

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:
Hypertension
Infarction
Cardiovascular Diseases
Myocardial Infarction
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases

ClinicalTrials.gov processed this record on December 02, 2016