Ischaemic heart disease in postmenopausal women Circulatory System Ischaemic heart disease
Conditions
Interventions
Patients will be given 60 mg per day of raloxifen or placebo for three months, there is a one-month washing period and they are crossed to the other treatment (raloxifen for those who received placebo
Sponsors
Hospital Clínic of Barcelona (Spain)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women, aged less than 70 years 2. Estradiol and Follicle Stimulating Hormone (FSH) plasma concentrations less than 30 pg/mL and more than 40 UI/L, respectively 3. Confirmed coronary artery disease by coronary angiography (at least one vessel with stenosis more than 70%) and/or previous myocardial infarction 4. Signature of the informed consent to participate in the study and to undergo all the tests included in the trial
Exclusion criteria
Exclusion criteria: 1. History of gynaecological or other conditions that contraindicate treatment with raloxifen: a. Deep vein thrombosis, pulmonary embolism, retina venous thrombosis b. Hypersensitivity to raloxifen c. Increase of hepatic enzymes including colestasis d. Undiagnosed endometrial bleeding e. Endometrial cancer f. Breast cancer 2. Kidney failure (creatinine greater than 2 mg/dl) 3. Participation in another clinical study during 30 days prior to the randomisation 4. Hormone replacement therapy in the last six months
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To determine the effect of raloxifen on: 1. Coagulation fibrinolysis system 2. Platelet aggregation 3. Adhesion mollecules 4. Cytokines 5. C-Reactive Protein (CRP) 6. Lipid profile | — |
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of the three-months treatment with raloxifen versus placebo on endothelial function (humeral artery) in postmenopausal women with confirmed ischaemic heart disease. | — |
Countries
Spain
Outcome results
None listed