Effect of Drug Therapy on Reinfarction Risk in Women

February 8, 2016 updated by: University of Washington
To evaluate the safety of calcium-channel blockers in the secondary prevention of myocardial infarction in women.

Study Overview

Status

Completed

Conditions

Detailed Description

BACKGROUND:

Research on heart disease in the 196Os and 197Os was primarily concerned with risk factors for 'premature' atherosclerosis, which was most dramatically apparent in working middle-aged men who suffered heart attacks or died suddenly. This focus on 'premature' disease was an important initial step, but it resulted in a relative neglect of studies in older adults and in all women. Coronary heart disease remains nonetheless a major cause of morbidity and mortality among women.

Given the consistent findings from clinical trials that calcium-channel blockers administered following myocardial infarction do not decrease the risk of death or reinfarction, and that some drugs of this class may actually increase the risk, it is unlikely that future trials of this therapy in women will be conducted. Yet the calcium-channel blockers are used with increasing frequency in women following myocardial infarction. The only ethical method of conducting studies of the safety of these drugs in women is through observational studies. Data from the study can help to guide clinical practice and can assist in the design of appropriate secondary prevention trials in women.

DESIGN NARRATIVE:

On-going studies of hormone-replacement therapy in women at Group Health Cooperative of Puget Sound (GHC) identified all female enrollees who suffered a first heart attack since 1986; the study expanded this inception cohort through 1996. Information from medical record review and GHC databases were used to assess risk factors and co-morbid conditions, both at entry into the cohort and up to ten years of follow-up, and to identify recurrent cardiovascular events and deaths. A complete record of prescription drug exposure during the follow-up period was obtained for each subject from the GHC computerized pharmacy database. Although the main hypothesis related to reinfarction risk in women, men were studied as well to facilitate comparison of the results of this observational study with those of the clinical trials. According to conservative estimates of the available sample size, the investigators had 86 percent power to detect a relative risk of 1.45 in women alone, and 85 percent power to detect a relative risk of 1.25 in men and women combined, for the association of calcium-channel blocker use with fatal or non-fatal reinfarction. The study also examined the safety and efficacy of other cardiovascular drugs commonly used in women after myocardial infarction, including angiotensin converting-enzyme inhibitors, lipid-lowering drugs, and estrogen replacement therapy.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1995

Study Completion

August 1, 1998

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 8, 2016

Last Verified

April 1, 2001

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4295
  • R01HL053375 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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