Coronary artery disease MedDRA version: 20.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: PROCORALAN
Product Name: S16257
Product Code: S16257
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVABRADINE
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female of any ethnic origin aged 18 years or older at the date of selection, - Patients with a clinically indicated coronary angiography, - Patients in sinus rhythm and heart rate equal or higher than 70 bpm, - Treatment with optimal dose of lipid lowering therapies including statins (unless not-tolerated) to ensure that LDL dosage is within recommended range following local practice, as well as recommended treatment for CAD. 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 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: - Primary percutaneous coronary intervention for acute myocardial infarction with ST elevation at selection visit; - Previous coronary artery bypass graft (CABG) surgery or probable need for CABG in the next 18 months; - Valvular disease likely to require surgery during the treatment period of the study; - Patients with transplanted heart; - Implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronisation therapy; - Known hypersensitivity to ivabradine; - Known hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption; - Myocardial infarction in the target coronary artery for IVUS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of ivabradine treatment for 18 months on atherosclerotic disease progression as assessed using coronary Intravascular Ultrasound (IVUS); Secondary Objective: - To evaluate the effect of ivabradine on coronary plaque composition and other plaque characteristics using Virtual Histology IVUS (VH-IVUS) and Optical Coherence Tomography (OCT), - To assess the effect of ivabradine on wall shear stress. - To evaluate the effect of ivabradine on atherosclerosis progression using quantitative coronary angiography, - To assess the effect of ivabradine on several clinical endpoints as well as safety. ;Primary end point(s): Nominal change in coronary Percent Atheroma Volume (PAV) ;Timepoint(s) of evaluation of this end point: From baseline to the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: From baseline to study end; Secondary end point(s): - Various imaging efficacy endpoints assessed by coronary IVUS, coronary VH-IVUS in a sub-population, coronary QCA, coronary OCT in a sub-population and WSS - Clinical efficacy endpoints - Safety endpoints | — |
Countries
Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Malaysia, Netherlands, Norway, Poland, Portugal, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom
Contacts
Public ContactClinical Studies Department
Institut de Recherches Internationales Servier
Outcome results
None listed