Condition category
Circulatory System
Date applied
31/01/2007
Date assigned
26/04/2007
Last edited
26/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Magda Heras

ORCID ID

Contact details

Department of Cardiology
Hospital Clínic of Barcelona
Barcelona
08036
Spain

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

Sponsor information

Organisation

Hospital Clínic of Barcelona (Spain)

Sponsor details

c/o Dr Magda Heras
Villarroel 170
Barcelona
08036
Spain

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes