WOMEN'S ANGIOGRAPHIC VITAMIN AND ESTROGEN TRIAL (WAVE)
Principal Investigator: Naji Younes, Ph.D.
This study was a randomized, controlled, factorial clinical trial to evaluate the use of selected interventions in reducing the progression of coronary atherosclerosis in women. Approximately four hundred-twenty eligible women were randomized into the clinical trial. The trial utilized a factorial design to test the effect of a regimen of hormonal replacement therapy (an estrogen, and a progestin, when appropriate) and a combination of the antioxidants vitamins C and E, on the progression of atherosclerotic lesions in the coronary arteries. This was accomplished with a multi-disciplined team of investigators from 7 Clinical Centers, a Statistical Coordinating Center (SCC), the National Heart, Lung, and Blood Institute (NHLBI) project office, one central serum chemistry laboratory, a central angiographic reading center and a central pharmacy have been assembled.
Contract funded by NIH/NHLBI, N01-HV-68165, 1996- 2001.)