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Home > "T" Clinical Trials Conditions > Trial of Aspirin and Vitamin E in Women (Women's Health Study - WHS)  Trial of Aspirin and Vitamin E in Women (Women's Health Study - WHS)
Trial of Aspirin and Vitamin E in Women (Women's Health Study - WHS)
For Condition: Cardiovascular Diseases,Cerebrovascular Disorders,Coronary Disease,Heart Diseases,Myocardial Infarction,Myocardial Ischemia,Vascular Diseases
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To evaluate the effects of vitamin E and low-dose aspirin in primary prevention of cardiovascular disease and cancer in apparently healthy women.
Details: BACKGROUND: Various doses of aspirin have been shown to be effective in preventing thrombosis or vascular occlusion in several clinical conditions. Short-term studies have documented the efficacy of aspirin in preventing occlusion of saphenous vein bypass grants, preventing myocardial infarction in patients with unstable angina, preventing transient ischemic attacks and stroke in men with cerebral vascular disease, preventing occlusion of injured coronary arteries following transluminal angioplasty and aiding in reducing myocardial infarction and total mortality in patients receiving fibrinolytic therapy. Additionally, aspirin has been effective in the secondary prevention of myocardial infarction in subjects with known coronary artery disease. The results of the Physicians' Health Study, a large-scale primary prevention trial of aspirin in male physicians, have shown a decrease in myocardial infarction, a non-significant increase in cerebral vascular events, and no difference in overall mortality. However, few studies have addressed the efficacy of aspirin in vascular diseases in women, and it is possible that the risk to benefit ratio may be different in women. Specifically, there have been no large primary prevention trials in women, who are at risk of coronary heart disease, especially after menopause. DESIGN NARRATIVE: The Women's Health Study (WHS) is a randomized, double-blind, placebo-controlled trial using a 2x2 factorial design. Participants were randomly assigned to either Vitamin E (600 IU every other day) or placebo; and to aspirin (100 mg every other day) or placebo. Approximately 1.75 million female health professionals were contacted by mail to determine if they were suitable for inclusion in the study. A three-month run-in phase was performed to screen out those with poor compliance. Randomization, which began in February 1993 and ended in January 1996, was stratified on five-year age groups. The primary endpoint is the reduction of the risk of all important vascular events (a combined endpoint of nonfatal myocardial infarction, nonfatal stroke, and total cardiovascular death) and a decrease in the incidence of total malignant neoplasms of epithelial cell origin. Compliance is measured by replies to a questionnaire sent out every year. Beginning in September 1996, the trial has been extended for five years through August 2001 to allow for additional follow-up and data analysis. A large blood specimen bank has been formed for 70 percent of trial participants for use in later analyses.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment
Minimum Age/Maximum Age: 45 Years/
Genders: Female
Protocol Entry Criteria: Healthy women, 45 years of age or older, with no previous history of cardiovascular disease or contraindications to aspirin.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JulieBuring, , Brigham and Women's Hospital
Additional Information:
Study ID Numbers: 69;
Study Start Date: September 1991
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000479
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Trial of Aspirin and Vitamin E in Women (Women's Health Study - WHS)
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