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
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 or disease|
|Acute Coronary Syndrome|
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|
|Estimated Enrollment :||400000 participants|
|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)|
|Study Start Date :||July 2003|
|Estimated Primary Completion Date :||June 2010|
|Estimated Study Completion Date :||June 2010|
- All cause mortality [ Time Frame: Due to follow up an average of 3 years. ]Mortality as tracked by the Office for National Statistics
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162187
|Principal Investigator:||Owen M Nicholas, PhD||University College, London|