Secondary Prevention in Acute Coronary Syndromes: A CALIBER Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University College, London.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Barts & The London NHS Trust
University of Leicester
Information provided by:
University College, London
ClinicalTrials.gov Identifier:
NCT01162187
First received: July 1, 2010
Last updated: July 13, 2010
Last verified: July 2010
  Purpose

All contemporary guidelines for secondary prevention in acute coronary syndromes recommend a combination of aspirin, beta-blockers, ACE-inhibitors and statins. Yet underutilisation of these drugs is common. We do not know in detail what drives underutilisation, nor what its long term consequences are for survival after discharge from hospital. Also unknown is whether potential adverse effects of underutilisation are the same for individual secondary prevention drugs.

This study will assess the impact of secondary prevention underutilisation on survival.


Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Secondary Prevention in Acute Coronary Syndromes: Long-term Survival in Relation to the Number and Combination of Evidence-based Therapies Prescribed Prior to Discharge (a CALIBER Study)

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: Due to follow up an average of 3 years. ] [ Designated as safety issue: No ]
    Mortality as tracked by the Office for National Statistics


Secondary Outcome Measures:
  • Competing risks between acute coronary syndrome phenotypes [ Time Frame: Due to follow up an average of 3 years. ] [ Designated as safety issue: No ]
    Stable Angina, Unstable Angina, STEMI and NSTEMI will be treated both as startpoints and endpoints in transitions between phenotypes.


Estimated Enrollment: 400000
Study Start Date: July 2003
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Using information from an England and Wales audit of acute coronary syndromes (the Myocardial Ischaemia National Audit Project (MINAP)) we aim to assess:

(i) Survival from first time MINAP-registered event to death as a function of secondary prevention medications: To what degree do the effects of medications (assumed equal, independent and additive) relate to patient survival? Is there evidence of a differential effect of discharge medications? (ii) (a) Survival from first time MINAP-registered event to death or second time MINAP-registered event as a function of secondary prevention medications: To what degree do the effects of medications (assumed equal, independent and additive) relate to competing risks? Is there evidence of a differential effect of discharge medications? (b) Survival from first time MINAP-registered event to death or second time MINAP-registered phenotyped as STEMI, NSTEMI or Unstable Angina. To what degree do the effects of medications (assumed equal, independent and additive) relate to competing risks? Is there evidence of a differential effect of discharge medications? (iii) What impact would ensuring all medication is taken have on event free survival?

This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals with data entered into the Myocardial Ischaemia National Audit Project (MINAP) database in England and Wales.

Criteria

Inclusion Criteria:

  • Individuals with Acute Coronary Syndrome who have been registered with the MINAP database.

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162187

Sponsors and Collaborators
University College, London
Barts & The London NHS Trust
University of Leicester
Investigators
Principal Investigator: Owen M Nicholas, PhD University College, London
  More Information

Additional Information:
Publications:
Responsible Party: Dr Owen Nicholas, University College London
ClinicalTrials.gov Identifier: NCT01162187     History of Changes
Other Study ID Numbers: CALIBER-09-02
Study First Received: July 1, 2010
Last Updated: July 13, 2010
Health Authority: United Kingdom: Department of Health

Keywords provided by University College, London:
secondary prevention
aspirin
beta blocker
ACE inhibitor
statin
acute coronary syndrome
myocardial infarction
unstable angina
trends

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014