Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure.
- Conditions
- MedDRA version: 14.1Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Coronary artery disease
- Registration Number
- EUCTR2009-011360-10-PT
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16850
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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7950
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.;Timepoint(s) of evaluation of this end point: Composite endpoint measured up to 42 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Efficacy and safety endpoints;Timepoint(s) of evaluation of this end point: Efficacy and safety endpoints measured up to 42 months