Acute Coronary Syndrome Clinical Trial
Official title:
Clopidogrel and Proton Pump Inhibitors: A Propensity Score Adjusted Cohort Study to Examine a Possible Interaction: A CALIBER Study
Patients who have experienced and survived non-ST segment elevation acute coronary syndromes are often prescribed a combination of aspirin and clopidogrel to thin the blood and prevent further acute coronary episodes. Both clopidogrel and aspirin may cause stomach bleeds and so a prophylactic proton pump inhibitor is frequently co-prescribed in order to prevent such bleeds. Recent mechanistic and observational studies suggest proton pump inhibitors may reduce the effectiveness of clopidogrel and so patients may not benefit as much as expected from combined aspirin and clopidogrel. The investigators propose a cohort study of patients prescribed clopidogrel + aspirin. Amongst these patients the investigators will measure the relative rate of acute coronary syndrome and death comparing patients with and without proton pump inhibitor treatment. To provide a more complete picture of the risks and benefits of treatment the investigators will also measure the relative rate of stomach bleeds in the same groups of patients. In addition, whether the inhibitory effect of proton pump inhibitors on the protective effect of clopidogrel is due to their inhibition of drug metabolising enzymes will be explored by assessing the effects of other drugs that inhibit the same enzymes.
Status | Completed |
Enrollment | 24471 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All patients registered in the GPRD from 1998 to date and receiving clopidogrel in combination with aspirin and with at least 12 months up to standard observation before the first prescription for clopidogrel will be eligible for inclusion Exclusion Criteria: - Data will be restricted to 1998 onwards as this is the year clopidogrel was licensed in the UK. |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | London School of Hygiene & Tropical Medicine | London |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine | University College, London |
United Kingdom,
Gilard M, Arnaud B, Cornily JC, Le Gal G, Lacut K, Le Calvez G, Mansourati J, Mottier D, Abgrall JF, Boschat J. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin: the randomized, double-blind OCLA (Omeprazole CLopidogrel Aspirin) study. J Am Coll Cardiol. 2008 Jan 22;51(3):256-60. doi: 10.1016/j.jacc.2007.06.064. — View Citation
Gilard M, Arnaud B, Le Gal G, Abgrall JF, Boschat J. Influence of omeprazol on the antiplatelet action of clopidogrel associated to aspirin. J Thromb Haemost. 2006 Nov;4(11):2508-9. Epub 2006 Aug 8. — View Citation
Ho PM, Peterson ED, Wang L, Magid DJ, Fihn SD, Larsen GC, Jesse RA, Rumsfeld JS. Incidence of death and acute myocardial infarction associated with stopping clopidogrel after acute coronary syndrome. JAMA. 2008 Feb 6;299(5):532-9. doi: 10.1001/jama.299.5.532. Erratum in: JAMA. 2008 May 28;299(20):2390. — View Citation
Juurlink DN, Gomes T, Ko DT, Szmitko PE, Austin PC, Tu JV, Henry DA, Kopp A, Mamdani MM. A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ. 2009 Mar 31;180(7):713-8. doi: 10.1503/cmaj.082001. Epub 2009 Jan 28. — View Citation
Sibbing D, Morath T, Stegherr J, Braun S, Vogt W, Hadamitzky M, Schömig A, Kastrati A, von Beckerath N. Impact of proton pump inhibitors on the antiplatelet effects of clopidogrel. Thromb Haemost. 2009 Apr;101(4):714-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to composite end point of all cause mortality OR incident myocardial infarction (MI) | up to 12 years | Yes | |
Secondary | Time to incident gastrointestinal (GI) bleed. | up to 12 years | Yes | |
Secondary | Time to incident myocardial infarction | up to 12 years | Yes |
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