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The Risk of Myocardial Infarction in Users of Antipsychotic Agents

NCT ID: NCT01236274

Last Updated: 2010-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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).

The use of antipsychotics is associated with a rise in cardiovascular events. Previous studies investigating the effect of antipsychotic agents on the risk of Myocardial Infarction (MI) led to conflicting results with reports of either no association or a positive association. As patient populations for whom antipsychotic agents are indicated differ considerably from healthy comparison populations, confounding by indication could be substantial. Whilst confounding can be accounted for if known and measured, residual confounding remains a potential problem. 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 explore the role of confounding by indication.

Conditions

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Myocardial Infarction

Keywords

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Myocardial Infarction Antipsychotic agents Self-controlled case series method General Practice Research Database Myocardial Ischaemia National Audit Project CALIBER

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Antipsychotic agents AND MI

In the self-controlled case series study, patients who experienced a myocardial infarction and received an antipsychotic agent during up to standard (UTS) follow-up in the GPRD will be included and will act as their own control.

No interventions assigned to this group

Myocardial Infarction

In the case-control study, all cases with a first recorded occurrence of MI during up to standard (UTS) follow-up in the GPRD will be identified

No interventions assigned to this group

No Myocardial Infarction

In the case-control study, a control group with subjects who never experienced a myocardial infarction will be matched to cases (5:1) by age, gender, General Practitioner and registration in the GPRD on the date of MI of the case

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients in GPRD practices that agreed to linkage with the MINAP database
* Age over 18
* Self-controlled case-series: patients who received an antipsychotic agent during up to standard (UTS) follow-up in the GPRD
* Self-controlled case-series: patients who experienced a first record of MI at least 12 months after the start of UTS follow-up period in the GPRD data record

Exclusion Criteria

* Patients will be excluded after experiencing their first MI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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London School of Hygiene and Tropical Medicine

Principal Investigators

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Ruth Brauer

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Harry Hemingway, FRCP

Role: STUDY_DIRECTOR

University College, London

Locations

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London School of Hygiene and Tropical Medicine

London, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://www.caliberresearch.org/

Related Info

Other Identifiers

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10-01

Identifier Type: -

Identifier Source: org_study_id