MEnopause and Raloxifen in ischaemic Coronary disease: effects on Endothelial Dysfunction
| ISRCTN | ISRCTN31608625 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31608625 |
| Protocol serial number | 03-0579 |
| Sponsor | Hospital Clínic of Barcelona (Spain) |
| Funder | 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) |
- Submission date
- 31/01/2007
- Registration date
- 26/04/2007
- Last edited
- 09/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Magda Heras
Scientific
Scientific
Department of Cardiology
Hospital Clínic of Barcelona
Barcelona
08036
Spain
Study information
| Primary study design | Interventional |
|---|---|
| Study design | This study is a national, multicentre, double blind, cross-over study, with randomly assigned periods |
| Secondary study design | Single-centre |
| Scientific title | MEnopause and Raloxifen in ischaemic Coronary disease: effects on Endothelial Dysfunction |
| Study acronym | MERCED |
| Study objectives | 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(s) | Approval received from the ethics committee of the Spanish Drug Agency (Agencia Espanola del Medicamento) on the 2nd March 2004 (ref: 03-0579). |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Raloxifen |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
To determine the effect of raloxifen on: |
| Completion date | 31/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 60 |
| Total final enrolment | 33 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 31/07/2005 |
Locations
Countries of recruitment
- Spain
Study participating centre
Department of Cardiology
Barcelona
08036
Spain
08036
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2011 | 09/05/2019 | Yes | No |
Editorial Notes
09/05/2019: Publication reference and total final enrolment added.
