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Postmenopausal Hormone Therapy in Unstable Angina

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000601
First Posted: October 28, 1999
Last Update Posted: February 18, 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 determine if estrogen therapy in postmenopausal women with unstable angina reduces the incidence of ischemic episodes.

Condition Intervention Phase
Angina, Unstable Cardiovascular Diseases Coronary Disease Heart Diseases Postmenopause Drug: estrogen replacement therapy Drug: estrogens Drug: progesterone Drug: hormone replacement therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Prevention

Resource links provided by NLM:


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

Study Start Date: July 1995
Study Completion Date: June 2000
Detailed Description:

BACKGROUND:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
Postmenopausal women with unstable angina.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000601     History of Changes
Other Study ID Numbers: 107
R01HL050839 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: February 18, 2016
Last Verified: February 2005

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Angina, Unstable
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hormones
Progesterone
Estrogens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins