Women's Angiographic Vitamin and Estrogen Trial (WAVE)

Sponsor

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000555

Collaborator

(none)

Duration (Months)

Study Details

Study Description

Brief Summary

To assess whether hormonal replacement therapy and/or antioxidant treatment would stabilize or inhibit progression, and induce regression of coronary plaques. The mechanisms by which these treatments modified atherosclerosis in women were also explored.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Coronary Arteriosclerosis Coronary Disease Heart Diseases Myocardial Ischemia Postmenopause	Drug: estrogen replacement therapy Drug: estrogens, conjugated Drug: progesterone Drug: hormone replacement therapy Drug: supplementation, food Drug: ascorbic acid Drug: vitamin e	Phase 3

Detailed Description

BACKGROUND:

Coronary artery disease is the leading cause of death in the United States, accounting for over 500,000 deaths each year. Although the onset of coronary artery disease is delayed in women, it is the single most important cause of death in women over the entire life span. Indeed, because more women than men survive to old age, mortality due to coronary artery disease for all ages combined is as great in women as in men. Furthermore, once they present with clinical evidence of coronary artery disease, women have a prognosis as poor as, or even worse, than that for men. In part, this may be due to late recognition of coronary artery disease in women, less intensive treatment of women, or a more adverse risk profile in women who develop coronary artery disease. The report of a recent Working Group on Angiographic Trials of Atherosclerosis Prevention notes that, compared to males, females who develop coronary artery disease, have various different characteristics which may affect the vascular response to lipid-altering interventions. These differences led the report to question whether the mechanisms and clinical benefits of lipid-altering agents may be different in men and women. It further noted that angiographic trials conducted to date have been based primarily upon the cholesterol-lowering treatments of diet or drugs and suggested that other approaches based upon the lipid hypothesis could profitably be tested and should be given the highest priority at this time; specifically recommended were trials of hormone replacement and antioxidant therapy in women.

DESIGN NARRATIVE:

Subjects were randomized into a 2 x 2 factorial trial of hormone replacement therapy and antioxidant therapy. Women were randomized into four treatment groups: both active hormone replacement and antioxidant; active hormone replacement therapy and antioxidant placebo; active antioxidant therapy and hormone replacement placebo; double placebo plus usual care. Hormone replacement therapy consisted of estrogen plus a progestin (PremPro) for all gynecologically intact women, and unopposed estrogen (Premarin) for women with hysterectomies. Antioxidants consisted of a combination of vitamin E and vitamin C. Angiographic change was a primary endpoint of this trial. The study was double-blind to the extent permitted by the interventions; however, it was fully-blinded with respect to outcome variables. Recruitment ended in August 1999. The mean duration of follow-up was approximately three years.

The NHLBI awarded R01HL68397 in April 2001 as an ancillary study to WAVE. The study entitled "Modifying Oxidative Damage in WAVE" has its on site on this database.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double

Primary Purpose:

Prevention

Study Start Date :

Aug 1, 1996

Actual Study Completion Date :

May 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

38 Years to 86 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Postmenopausal women, up to age 86, with angiographically documented coronary artery disease of at least 15 percent, but no more than 75 percent occlusion.