Women's Angiographic Vitamin and Estrogen Trial (WAVE)
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Accession Number
HLB00330404a
Study Type
Clinical Trial
Collection Type
Open BioLINCC Study
See bottom of this webpage for request information
Study Period
1996-2003
NHLBI Division
DCVS
Dataset(s) Last Updated
July 17, 2020
Clinical Trial URLs
https://clinicaltrials.gov/ct/show/NCT00000555
Primary Publication URLs
https://www.ncbi.nlm.nih.gov/pubmed/12435256
Consent
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Objectives
Determine the efficacy of estrogen replacement and antioxidant vitamins for preventing angiographic progression of coronary artery disease.
Background
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.
Participants
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.
Conclusions
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 Available
Study Datasets OnlyStudy Documents
- Data Dictionary (PDF - 1.7 MB)
- Manual of Operations (PDF - 745.8 KB)
- Protocol (PDF - 379.4 KB)
- Forms
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