Cohort Study of Clopidogrel and Proton Pump Inhibitors
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition |
|---|
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Coronary Heart Disease Acute Coronary Syndrome Drug Interactions Clopidogrel Proton Pump Inhibitors Gastrointestinal Hemorrhage |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Clopidogrel and Proton Pump Inhibitors: A Propensity Score Adjusted Cohort Study to Examine a Possible Interaction: A CALIBER Study |
- Time to composite end point of all cause mortality OR incident myocardial infarction (MI) [ Time Frame: up to 12 years ] [ Designated as safety issue: Yes ]
- Time to incident gastrointestinal (GI) bleed. [ Time Frame: up to 12 years ] [ Designated as safety issue: Yes ]
- Time to incident myocardial infarction [ Time Frame: up to 12 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40000 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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. Data will be restricted to 1998 onwards as this is the year clopidogrel was licensed in the UK.
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.
Contacts and Locations| United Kingdom | |
| London School of Hygiene & Tropical Medicine | Not yet recruiting |
| London, United Kingdom, WC1E 7HT | |
| Contact: Ian Douglas 44(0)2079272968 ian.douglas@lshtm.ac.uk | |
| Principal Investigator: | Ian J Douglas, PhD, MSc | London School of Hygiene and Tropical Medicine |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Ian Douglas, London School of Hygiene and Tropical Medicine |
| ClinicalTrials.gov Identifier: | NCT01231867 History of Changes |
| Other Study ID Numbers: | 09_042, CALIBER 09_09 |
| Study First Received: | October 18, 2010 |
| Last Updated: | December 5, 2010 |
| Health Authority: | United Kingdom: Research Ethics Committee United Kingdom: CALIBER Scientific Oversight Committee |
Keywords provided by London School of Hygiene and Tropical Medicine:
|
Coronary Heart Disease Acute Coronary Syndrome Drug interactions |
Clopidogrel Proton Pump Inhibitors Gastrointestinal Hemorrhage |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Gastrointestinal Hemorrhage Heart Diseases Hemorrhage Acute Coronary Syndrome Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Gastrointestinal Diseases Digestive System Diseases Pathologic Processes Angina Pectoris |
Chest Pain Pain Signs and Symptoms Clopidogrel Proton Pump Inhibitors Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013