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Women's Angiographic Vitamin and Estrogen Trial (WAVE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000555
First Posted: October 28, 1999
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Prevention

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: August 1996
Study Completion Date: May 2003
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   38 Years to 86 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
Postmenopausal women, up to age 86, with angiographically documented coronary artery disease of at least 15 percent, but no more than 75 percent occlusion.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000555


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Joel Verter George Washington University
  More Information

Publications:

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: WAVE
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.

ClinicalTrials.gov Identifier: NCT00000555     History of Changes
Other Study ID Numbers: 99
N01HV68165 ( U.S. NIH Grant/Contract )
N01HV68166 ( U.S. NIH Grant/Contract )
N01HV68167 ( U.S. NIH Grant/Contract )
N01HV68168 ( U.S. NIH Grant/Contract )
N01HV68169 ( U.S. NIH Grant/Contract )
N01HV68170 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: July 12, 2016
Last Verified: August 2005

Additional relevant MeSH terms:
Estrogens, Conjugated (USP)
Estrogens
Cardiovascular Diseases
Heart Diseases
Ischemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
Pathologic Processes
Vascular Diseases
Arterial Occlusive Diseases
Vitamins
Vitamin E
Ascorbic Acid
Hormones
Progesterone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Progestins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents