Effects of ivabradine on cardiovascular events in patients with stable coronary artery disease and left ventricular systolic dysfunction. A three-year randomised double-blind placebo-controlled international multicentre study. - BEAUTIF
- Conditions
- Coronary artery diseaseMedDRA version: 7.0Level: PTClassification code 10011078
- Registration Number
- EUCTR2004-001959-11-HU
- Lead Sponsor
- Institut de Recherches Internationales
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 9650
The main inclusion criteria will be:
(1) history of coronary artery disease documented on a coronary angiography or by a previous myocardial infarction or a coronary revascularisation and
(2) left ventricular systolic dysfunction defined as a left ventricular ejection fraction equal to 39% or lower on a two-dimensional echocardiography and a left ventricular dilatation defined as an echocardiographically measured short-axis internal dimension greater than 56 millimetres and
(3) sinus rhythm and resting heart rate equal to or higher than 55 beats per minute and
(4) informed consent obtained.
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
The main exclusion criteria will be:
(1) unstable cardiovascular condition
(2) severe congestive heart failure (class IV of the classification of the New-York Heart Association)
(3) contra-indications to the administration of ivabradine.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method