EUCTR2004-001959-11-LT
Active, not recruiting
Not Applicable
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
Institut de Recherches Internationales0 sites9,650 target enrollmentDecember 10, 2004
ConditionsCoronary artery diseaseMedDRA version: 8.1Level: LLTClassification code 10011078Term: Coronary artery disease
DrugsPROCORALAN
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary artery disease
- Sponsor
- Institut de Recherches Internationales
- Enrollment
- 9650
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 60 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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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