Women's Angiographic Vitamin and Estrogen Trial (WAVE)

NCT00000555 | Completed Phase 3

• 7 other identifiers: 99N01HV68165N01HV68166N01HV68167N01HV68168N01HV68169N01HV68170
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Myocardial Ischemia; Postmenopause

Interventions

estrogen replacement therapy DRUG

estrogens, conjugated DRUG

progesterone DRUG

hormone replacement therapy DRUG

supplementation, food DRUG

ascorbic acid DRUG

vitamin e DRUG

Eligibility Criteria

• Age: 38 Years - 86 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (8)

• 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.

  PMID: 12435256 BACKGROUND

• 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.

  PMID: 12505248 BACKGROUND

• 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.

  PMID: 12947360 BACKGROUND

• 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.

  PMID: 15226212 BACKGROUND

• 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.

  PMID: 15047650 BACKGROUND

• 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.

  PMID: 15308999 BACKGROUND

• 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.

  PMID: 15721027 BACKGROUND

• 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.

  PMID: 16054453 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Coronary Disease; Heart Diseases; Myocardial Ischemia

Interventions

Estrogen Replacement Therapy; Estrogens, Conjugated (USP); Progesterone; Hormone Replacement Therapy; Dietary Supplements; Food; Ascorbic Acid; Vitamin E

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Progesterone Congeners; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Joel Verter

  George Washington University

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: August 1, 1996
• Study Completion: May 1, 2003
• Last Updated: July 12, 2016

Record last verified: 2005-08