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The Risk of Myocardial Infarction in Users of Antipsychotic Agents

NCT01236274 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 90000

Last updated 2010-11-08

No results posted yet for this study

Summary

A number of studies have suggested an association between the use of antipsychotic agents and cardiovascular mortality. However, the relationship between cardiac events and the use of antipsychotic drugs is not clear. Patients experiencing psychoses and in need for antipsychotic agents may be at a higher risk of cardiac events regardless of any effect of antipsychotic medication. Two studies have specifically investigated the association between the use of antipsychotics and the risk of cardiac events using Myocardial Infarction (MI) as an outcome measure, reporting no association and a positive association respectively. This difference in results may be explained by the use of different measures as well as study designs in both studies and because of different limitations with regard to controlling for lifestyle and medical risk factors. This study aims to assess the relationship between the risk of MI and recent exposure to antipsychotic agents by using the self-controlled case series method with which we are able to control for fixed confounders. The results of the self-controlled case series method will be compared to the results of a case-control study using the same data to compare the estimates of both methods.

Conditions

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Ruth Brauer · London School of Hygiene and Tropical Medicine

  • Harry Hemingway, FRCP · University College, London

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-12-31
Completion
2014-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01236274 on ClinicalTrials.gov