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Secondary Prevention in Acute Coronary Syndromes: A CALIBER Study

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ClinicalTrials.gov Identifier: NCT01162187
Recruitment Status : Unknown
Verified July 2010 by University College, London.
Recruitment status was:  Active, not recruiting
First Posted : July 14, 2010
Last Update Posted : July 14, 2010
Sponsor:
Collaborators:
Barts & The London NHS Trust
University of Leicester
Information provided by:
University College, London

Tracking Information
First Submitted Date July 1, 2010
First Posted Date July 14, 2010
Last Update Posted Date July 14, 2010
Study Start Date July 2003
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 13, 2010)
All cause mortality [ Time Frame: Due to follow up an average of 3 years. ]
Mortality as tracked by the Office for National Statistics
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 13, 2010)
Competing risks between acute coronary syndrome phenotypes [ Time Frame: Due to follow up an average of 3 years. ]
Stable Angina, Unstable Angina, STEMI and NSTEMI will be treated both as startpoints and endpoints in transitions between phenotypes.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Secondary Prevention in Acute Coronary Syndromes: A CALIBER Study
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)
Brief Summary

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.

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).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals with data entered into the Myocardial Ischaemia National Audit Project (MINAP) database in England and Wales.
Condition Acute Coronary Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 13, 2010)
400000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2010
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01162187
Other Study ID Numbers CALIBER-09-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Owen Nicholas, University College London
Study Sponsor University College, London
Collaborators
  • Barts & The London NHS Trust
  • University of Leicester
Investigators
Principal Investigator: Owen M Nicholas, PhD University College, London
PRS Account University College, London
Verification Date July 2010