Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study. - SIGNIFY
- Conditions
- Coronary artery diseaseMedDRA version: 12.0Level: LLTClassification code 10011078Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2009-011360-10-HU
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 11330
Inclusion Criteria
- Aged 55 years or older,
- Male or female,
- Patients with stable coronary artery disease without clinical heart failure,
- Sinus rhythm and resting heart rate equal or higher than 70 bpm.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Unstable cardiovascular condition,
- Contra-indications to the administration of ivabradine or current treatment with marketed ivabradine.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.;Secondary Objective: Efficacy and safety.;Primary end point(s): Composite endpoint made of cardiovascular mortality or non fatal myocardial infarction.
- Secondary Outcome Measures
Name Time Method