Effect of Drug Therapy on Reinfarction Risk in Women

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005389
• Other study ID #: 4295
• Secondary ID: R01HL053375
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: February 8, 2016
• Start date: September 1995
• Est. completion date: August 1998

Study information

• Verified date: April 2001
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To evaluate the safety of calcium-channel blockers in the secondary prevention of myocardial infarction in women.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 1998
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Myocardial Infarction

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (2)

Heckbert SR, Weiss NS, Koepsell TD, Lemaitre RN, Smith NL, Siscovick DS, Lin D, Psaty BM. Duration of estrogen replacement therapy in relation to the risk of incident myocardial infarction in postmenopausal women. Arch Intern Med. 1997 Jun 23;157(12):1330-6. — View Citation

Kaplan RC, Heckbert SR, Weiss NS, Wahl PW, Smith NL, Newton KM, Psaty BM. Postmenopausal estrogens and risk of myocardial infarction in diabetic women. Diabetes Care. 1998 Jul;21(7):1117-21. — View Citation