MEnopause and Raloxifen in ischaemic Coronary disease: effects on Endothelial Dysfunctio
- Conditions
- Ischaemic heart disease in postmenopausal womenCirculatory SystemIschaemic heart disease
- Registration Number
- ISRCTN31608625
- Lead Sponsor
- Hospital Clínic of Barcelona (Spain)
- Brief Summary
2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21601973 (added 09/05/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 33
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method <br> To determine the effect of raloxifen on:<br> 1. Coagulation fibrinolysis system<br> 2. Platelet aggregation<br> 3. Adhesion mollecules<br> 4. Cytokines<br> 5. C-Reactive Protein (CRP)<br> 6. Lipid profile<br>