Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
03-0579
Study information
Scientific title
Acronym
MERCED
Study hypothesis
Treatment with raloxifen improves vascular reactivity in menopausal patients with ischaemic coronary disease. This improvement can be measured reliably by non-invasive methods.
Ethics approval
Approval received from the ethics committee of the Spanish Drug Agency (Agencia Espanola del Medicamento) on the 2nd March 2004 (ref: 03-0579).
Study design
This study is a national, multicentre, double blind, cross-over study, with randomly assigned periods
Primary study design
Interventional
Secondary study design
Single-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Ischaemic heart disease in postmenopausal women
Intervention
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 and palcebo for those treated with raloxifen) for another three months. Patients and researchers will be blinded to the treatment throughout the trial. At the end of each period, the endothelial dependent vasodilatation will be measured together with several markers of disease (includig inflammation and thrombosis).
Intervention type
Drug
Phase
Not Specified
Drug names
Raloxifen
Primary outcome measures
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
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
Overall trial start date
01/01/2004
Overall trial end date
31/07/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60
Participant 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
Recruitment start date
01/01/2004
Recruitment end date
31/07/2005
Locations
Countries of recruitment
Spain
Trial participating centre
Department of Cardiology
Barcelona
08036
Spain
Funders
Funder type
Government
Funder name
This work was funded in part by the Ministerio de Sanidad y Consumo, Instituto de Salud Carlos III (Spain) (ref: Red HERACLES REDG03/045-0 and PI050038)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary