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Cardiovascular DiseasesPhase 3NCT00000555

Women's Angiographic Vitamin and Estrogen Trial (WAVE)

A Phase 3 study testing estrogen replacement therapy, estrogens, conjugated and progesterone in people with Cardiovascular Diseases and Coronary Arteriosclerosis, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 38 to 86 years, women only
What is being tested?
estrogen replacement therapy, estrogens, conjugated and progesterone
How many people
Not given
Where
No sites listed yet
Study dates
Aug 1996to May 2003
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 38 to 86 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

About this study

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.

Read the 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.

Being tested
estrogen replacement therapy, estrogens, conjugated, progesterone, hormone replacement therapy, supplementation, food
Medical subject headings
Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Heart Diseases, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • estrogen replacement therapyDrug

  • estrogens, conjugatedDrug

  • progesteroneDrug

  • hormone replacement therapyDrug

  • supplementation, foodDrug

  • ascorbic acidDrug

  • vitamin eDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 1999 (estimated)
  2. Study startAug 1996
  3. Study completionMay 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000555
Sponsor's protocol ID
99
Other IDs
N01HV68165, N01HV68166, N01HV68167, N01HV68168, N01HV68169, N01HV68170
Status last verified
Aug 2005
First submitted
27 Oct 1999
Last updated
12 Jul 2016
Results posted
No

Publications

  • Waters DD, Alderman EL, Hsia J, Howard BV, Cobb FR, Rogers WJ, Ouyang P, Thompson P, Tardif JC, Higginson L, Bittner V, Steffes M, Gordon DJ, Proschan M, Younes N, Verter JI. Effects of hormone replacement therapy and antioxidant vitamin supplements on coronary atherosclerosis in postmenopausal women: a randomized controlled trial. JAMA. 2002 Nov 20;288(19):2432-40. doi: 10.1001/jama.288.19.2432.

    PubMed 12435256

  • Hsia J, Alderman EL, Verter JI, Rogers WJ, Thompson P, Howard BV, Cobb FR, Ouyang P, Tardif JC, Higginson L, Bittner V, Barofsky I, Steffes M, Gordon DJ, Proschan M, Younes N, Waters D. Women's angiographic vitamin and estrogen trial: design and methods. Control Clin Trials. 2002 Dec;23(6):708-27. doi: 10.1016/s0197-2456(02)00237-4.

    PubMed 12505248

  • Hsia J, Bittner V, Tripputi M, Howard BV. Metabolic syndrome and coronary angiographic disease progression: the Women's Angiographic Vitamin & Estrogen trial. Am Heart J. 2003 Sep;146(3):439-45. doi: 10.1016/S0002-8703(03)00227-8.

    PubMed 12947360

  • Howard BV, Hsia J, Ouyang P, Van Voorhees L, Lindsay J, Silverman A, Alderman EL, Tripputi M, Waters DD. Postmenopausal hormone therapy is associated with atherosclerosis progression in women with abnormal glucose tolerance. Circulation. 2004 Jul 13;110(2):201-6. doi: 10.1161/01.CIR.0000134955.93951.D5. Epub 2004 Jun 28.

    PubMed 15226212

  • Levy AP, Friedenberg P, Lotan R, Ouyang P, Tripputi M, Higginson L, Cobb FR, Tardif JC, Bittner V, Howard BV. The effect of vitamin therapy on the progression of coronary artery atherosclerosis varies by haptoglobin type in postmenopausal women. Diabetes Care. 2004 Apr;27(4):925-30. doi: 10.2337/diacare.27.4.925.

    PubMed 15047650

  • Bittner V, Tripputi M, Hsia J, Gupta H, Steffes M; Women's Angiographic Vitamin & Estrogen Investigators. Remnant-like lipoproteins, hormone therapy, and angiographic and clinical outcomes: the Women's Angiographic Vitamin & Estrogen Trial. Am Heart J. 2004 Aug;148(2):293-9. doi: 10.1016/j.ahj.2004.01.025.

    PubMed 15308999

  • Kelemen M, Vaidya D, Waters DD, Howard BV, Cobb F, Younes N, Tripputti M, Ouyang P. Hormone therapy and antioxidant vitamins do not improve endothelial vasodilator function in postmenopausal women with established coronary artery disease: a substudy of the Women's Angiographic Vitamin and Estrogen (WAVE) trial. Atherosclerosis. 2005 Mar;179(1):193-200. doi: 10.1016/j.atherosclerosis.2004.09.021. Epub 2004 Dec 28.

    PubMed 15721027

  • Ruo B, Tripputi MT, Hsue PY, Saigo M, Ouyang P, Waters DD. Usefulness of serum endothelin levels in predicting death and myocardial infarction but not coronary progression in postmenopausal women with coronary disease (from the Women's Angiographic Vitamin and Estrogen [WAVE] study). Am J Cardiol. 2005 Aug 1;96(3):335-8. doi: 10.1016/j.amjcard.2005.03.071.

    PubMed 16054453

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing estrogen replacement therapy, estrogens, conjugated and progesterone in people with Cardiovascular Diseases and Coronary Arteriosclerosis, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000555, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.

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