MEnopause and Raloxifen in ischaemic Coronary disease: effects on Endothelial Dysfunction

ISRCTN ISRCTN31608625
DOI https://doi.org/10.1186/ISRCTN31608625
Secondary identifying numbers 03-0579
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

Department of Cardiology
Hospital Clínic of Barcelona
Barcelona
08036
Spain

Study information

Study designThis study is a national, multicentre, double blind, cross-over study, with randomly assigned periods
Primary study designInterventional
Secondary study designSingle-centre
Study setting(s)Not specified
Study typeTreatment
Scientific titleMEnopause and Raloxifen in ischaemic Coronary disease: effects on Endothelial Dysfunction
Study acronymMERCED
Study objectivesTreatment 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) studiedIschaemic heart disease in postmenopausal women
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Raloxifen
Primary outcome measureTo 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 measuresTo 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 study start date01/01/2004
Completion date31/07/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants60
Total final enrolment33
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2004
Date of final enrolment31/07/2005

Locations

Countries of recruitment

  • Spain

Study participating centre

Department of Cardiology
Barcelona
08036
Spain

Sponsor information

Hospital Clínic of Barcelona (Spain)
Hospital/treatment centre

c/o Dr Magda Heras
Villarroel 170
Barcelona
08036
Spain

ROR logo "ROR" https://ror.org/02a2kzf50

Funders

Funder type

Government

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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.