Clinical trial NCT01162187: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Keywords: secondary prevention
aspirin
beta blocker
ACE inhibitor
statin
acute coronary syndrome
myocardial infarction
unstable angina
trends
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Barts & The London NHS Trust
name: University of Leicester
First posted: 2010-07-14
Enrollment: 400000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with data entered into the Myocardial Ischaemia National Audit Project (MINAP) database in England and Wales.

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: All cause mortality
timeFrame: Due to follow up an average of 3 years.
Secondary outcomes:
measure: Competing risks between acute coronary syndrome phenotypes
timeFrame: Due to follow up an average of 3 years.
Other outcomes:
Locations:
Study officials:
affiliation: University College, London
name: Owen M Nicholas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: National Collaborating Centre for Primary Care (UK). Post Myocardial Infarction: Secondary Prevention in Primary and Secondary Care for Patients Following a Myocardial Infarction [Internet]. London: Royal College of General Practitioners (UK); 2007 May. Available from http://www.ncbi.nlm.nih.gov/books/NBK49343/
citation: Goodman SG, Huang W, Yan AT, Budaj A, Kennelly BM, Gore JM, Fox KA, Goldberg RJ, Anderson FA Jr; Expanded Global Registry of Acute Coronary Events (GRACE2) Investigators. The expanded Global Registry of Acute Coronary Events: baseline characteristics, management practices, and hospital outcomes of patients with acute coronary syndromes. Am Heart J. 2009 Aug;158(2):193-201.e1-5. doi: 10.1016/j.ahj.2009.06.003.
citation: Chew DP, Anderson FA, Avezum A, Eagle KA, FitzGerald G, Gore JM, Dedrick R, Brieger D; GRACE Investigators. Six-month survival benefits associated with clinical guideline recommendations in acute coronary syndromes. Heart. 2010 Aug;96(15):1201-6. doi: 10.1136/hrt.2009.184853. Epub 2010 Jun 7.
citation: Bramlage P, Messer C, Bitterlich N, Pohlmann C, Cuneo A, Stammwitz E, Tebbenjohanns J, Gohlke H, Senges J, Tebbe U. The effect of optimal medical therapy on 1-year mortality after acute myocardial infarction. Heart. 2010 Apr;96(8):604-9. doi: 10.1136/hrt.2009.188607. Epub 2010 Mar 29.