Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
INTERVENTIONAL
1995-07-31
2000-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Hormone Therapy Effects on CVD Risk Factors
NCT00006313
Estrogen Replacement and Atherosclerosis (ERA) in Older Women
NCT00000549
Stroke and MI in Users of Estrogen/Progestogen
NCT00005466
Estrogen, Cytokines and Heart Failure in Women
NCT00041431
Myocardial Infarction and Non-contraceptive Estrogen Use
NCT00005185
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Unstable angina is a frequent diagnosis in post-menopausal women and is associated with a significant risk of myocardial infarction and need for revascularization. The pathogenesis of unstable angina involves vasoconstriction superimposed on fixed disease, causing a temporary decrease in coronary blood flow. Recent catheterization studies in patients with atherosclerosis utilizing quantitative angiography and intracoronary doppler measurements of blood flow velocity suggest that endothelial dysfunction results in a paradoxical coronary vasoconstriction response to certain neurohumoral stimuli including acetylcholine, catecholamines, and serotonin with resultant myocardial ischemia. Therapeutic agents which prevent or limit this vasoconstriction may prevent recurrent ischemia and/or myocardial infarction in unstable angina patients. Recently, estrogen receptors were identified in the smooth muscle of post-mortem human coronary arteries. Work in animal models and studies in post-menopausal women suggest that intravenous estrogen acutely decreases coronary vascular resistance, increases coronary blood flow, and prevents the paradoxical response to acetylcholine in patients with endothelial dysfunction.
DESIGN NARRATIVE:
The randomized, double-blind, placebo-controlled, multi-center trial tested the hypothesis that intravenous estrogen followed by oral estrogen and the combination of intravenous and oral estrogen and progesterone in the routine management of unstable angina were beneficial compared with placebo in post-menopausal women. Subjects with rest angina and no contraindications to hormone therapy were randomized to receive intravenous followed by oral conjugated estrogen for 21 days, intravenous estrogen followed by oral conjugated estrogen plus medroxyprogesterone for 21 days or placebo. The primary end point was the number of ambulatory electrocardiographic ischemic events over the first 48 hours. Clinical events were also determined over six months of follow-up.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PREVENTION
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
estrogen replacement therapy
estrogens
progesterone
hormone replacement therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
45 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
References
Explore related publications, articles, or registry entries linked to this study.
Schulman SP, Thiemann DR, Ouyang P, Chandra NC, Schulman DS, Reis SE, Terrin M, Forman S, de Albuquerque CP, Bahr RD, Townsend SN, Cosgriff R, Gerstenblith G. Effects of acute hormone therapy on recurrent ischemia in postmenopausal women with unstable angina. J Am Coll Cardiol. 2002 Jan 16;39(2):231-7. doi: 10.1016/s0735-1097(01)01724-7.
Engelman RM, Pleet AB, Rousou JA, Flack JE 3rd, Deaton DW, Gregory CA, Pekow PS. What is the best perfusion temperature for coronary revascularization? J Thorac Cardiovasc Surg. 1996 Dec;112(6):1622-32; discussion 1632-3. doi: 10.1016/S0022-5223(96)70021-1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
107
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.