Cohort Study of Clopidogrel and Proton Pump Inhibitors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by London School of Hygiene and Tropical Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University College, London
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01231867
First received: October 18, 2010
Last updated: December 5, 2010
Last verified: December 2010
  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
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

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Study Population

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.

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01231867

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   
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
University College, London
Investigators
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:
Heart Diseases
Syndrome
Acute Coronary Syndrome
Hemorrhage
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Gastrointestinal Hemorrhage
Cardiovascular Diseases
Disease
Pathologic Processes
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Gastrointestinal Diseases
Digestive System Diseases
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

ClinicalTrials.gov processed this record on September 18, 2014