Coronary artery disease MedDRA version: 7.0 Level: PT Classification code 10011078
Conditions
Interventions
Product Name: Ivrabadine
Product Code: S16257-F42
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ivabradine
CAS Number: 155974-00-8
Current Sponsor code: S16257-02
Concentration unit: mg
Sponsors
Institut de Recherches Internationales
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality, hospital admission for acute myocardial infarction, hospital admissions for new onset or worsening heart failure (composite endpoint). ;Secondary Objective: The secondary objective is to assess the effect of ivabradine in the reduction of hospital admissions for acute coronary syndrome, hospital admissions for new onset or worsening heart failure, coronary revascularisations (composite endpoint), each endpoint of the previously mentioned composite endpoints, mortality related to coronary artery disease, total mortality, fatal and non-fatal myocardial infarctions. The tertiary objective is to assess the effect of ivabradine on the development of diabetes and metabolic syndrome, on the evolution of left ventricular ejection fraction, fractional shortening and end-diastolic dimension.;Primary end point(s): Primary objective (main purpose of the study), composite endpoint. Time to occurrence of the first event of one of the following: cardiovascular mortality, hospital admission for acute myocardial infarction, hospital admission for new onset or worsening heart failure. | — |
Countries
Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Spain, Sweden, United Kingdom
Outcome results
None listed