Coronary Heart Disease
Conditions
Keywords
Coronary Heart Disease, Hormone replacement therapy, Estrogen, Postmenopausal women
Brief summary
The purpose of the study is to determine whether hormone replacement therapy in post menopausal women with coronary artery disease prevents future heart attacks or death from coronary heart disease.
Detailed description
A randomized, blinded trial in post menopausal women with cornaornary artery disease to test the hypothesis, among 2340 women who have a uterus, that those randomized to receive estrogen-progestin replacement therapy (Premanrin .625 mg daily plus medroxygrprogesterone acetate 2.5 mg daily) have the same frequency on new CHD events (myocardial infarction and CHD death) as those randomized to placebo.
Interventions
DRUGPremarin .625 mg daily plus medroxyprogesterone 2.5 mg daily
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* \<75 y.o. * uterus present * postmenopausal * evidence of CHD * signed consent
Exclusion criteria
* MI, CABG, mechanical revascularization within 6 months * serum triglyceride \>300mg/dl * used hormone therapy or estrogen vaginal cream in past 3 months * history of DVT or pulmonary embolism * history of breast cancer or mammogram suggestive of cancer * history of endometrial cancer * abnormal uterine bleeding * pap smear abnormal * SGOT more than 1.2 times normal * Disease judged to be fatal within 4 yrs * alcoholism, drug abuse * NYHA Class IV congestive heart failure * uncontrolled hypertension * uncontrolled diabetes * participation in any other investigational study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial Infarction | — |
| CHD Death | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life | — |
| compliance | — |
| incidence of uterine bleeding and endometrial hyperplasia | — |
| incidencet and severity of vasomotor and genitourinary symptoms | — |
| adverse effects | — |
| thromboembolic events | — |
| CABG, revascularization, angina | — |
| fractures | — |
| cancer | — |
| stroke | — |
| peripheral arterial disease | — |
| total mortality | — |
| symptomatic gallbladder disease | — |
| serum lipids | — |
Countries
United States
Outcome results
None listed