Women's Angiographic Vitamin and Estrogen Trial (WAVE)
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October 13, 2008
August 8, 2005
Clinical Trial URLs
Primary Publication URLs
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Determine the efficacy of estrogen replacement and antioxidant vitamins for preventing angiographic progression of coronary artery disease.
Prior to the WAVE trial, Hormone Replacement Therapy (HRT) and antioxidant vitamins were widely used for primary and secondary prevention in postmenopausal women with coronary disease, but clincal trials had not yet demonstrated benefit to support these therapies.
Seven clinical centers randomized 423 postmenopausal women with one or more angiographically documented coronary vessel stenosis of 15-75%. The study design was a double blind, 2X2 factorial consisting of active hormone replacement therapy or placebo and active vitamins E and C or their placebos. Randomization was stratified for clinical center and prior hysterectomy. Women in the active arm of the HRT treatment received either conjugated equine estrogen (prior history of hysterectomy) or conjugated equine estrogen and medroxypregesterone acetate (women with a uterus). Women assigned to the active arm of the vitamin therapy took two capsules daily of vitamin E and two tablets daily of vitamin C. The primary endpoint was mean change in minimum lumen diameter as determined by angiography.
After a mean interval of 2.8 years, neither HRT nor antioxidant vitamin supplements provided cardiovascular benefit in postmenopausal women with coronary disease. Instead, a potential for harm was suggested with each treatment.(JAMA 2002; 288:2432-40)
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Resources AvailableStudy Datasets Only
- Data Dictionary (PDF - 1.7 MB)
- Manual of Operations (PDF - 745.8 KB)
- Protocol (PDF - 379.4 KB)
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