Secondary Prevention in Acute Coronary Syndromes: A CALIBER Study

Acute Coronary Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01162187
• Other study ID #: CALIBER-09-02
• Status: Active, not recruiting
• Phase: N/A
• First received: July 1, 2010
• Last updated: July 13, 2010
• Start date: July 2003
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400000
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	Barts & The London NHS Trust, University of Leicester

References & Publications (4)

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. — View 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. — View Citation

Cooper A, Skinner J, Nherera L, Feder G, Ritchie G, Kathoria M et al. Clinical Guidelines and Evidence Review for Post Myocardial Infarction: Secondary prevention in primary and secondary care for patients following a myocardial infarction. 2007. London, National Collaborating Centre for Primary Care and Royal College of General Practitioners. NICE Guidelines.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	Mortality as tracked by the Office for National Statistics	Due to follow up an average of 3 years.	No
Secondary	Competing risks between acute coronary syndrome phenotypes	Stable Angina, Unstable Angina, STEMI and NSTEMI will be treated both as startpoints and endpoints in transitions between phenotypes.	Due to follow up an average of 3 years.	No

External Links

•   CALIBER is based on linking the national myocardial infarction register to the rich longitudinal primary care record