Atherosclerosis/ hardening of the coronary arteries
Conditions
Interventions
None listed
Sponsors
Institut de Recherches Internationales Servier I.R.I.S
Eligibility
Age
18 Years to 99 Years
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.
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 |
|---|---|
| The primary endpoint for the assessment of atherosclerotic disease progression is the nominal change in coronary Percent Atheroma Volume (PAV) from baseline to the study end for all anatomically comparable slices in a 30-mm segment of the target coronary artery assessed by Intravascular Ultrasound (IVUS). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Coronary IVUS endpoints, nominal changes from baseline to study end: Total atheroma volume for all anatomically comparable slices in the 30-mm target coronary artery segment. Atheroma volume for the 5-mm segment centered on the cross-section with largest plaque area at baseline. Atheroma volume for the 5-mm segment centered on the cross-section with smallest plaque area at baseline. Total vessel volume for all anatomically comparable slices in the 30-mm target coronary artery segment. Plaque characterisation indices (arc index and inner perimeter index). - Coronary VH-IVUS endpoints, assessed in a sub-population (see section 8.2.2.5), nominal changes from baseline to study end: Necrotic core volume. Volumes of fibrofatty plaque and fibrous plaque. - Coronary QCA endpoints, nominal changes from baseline to study end: Coronary artery score (defined as the per-patient mean of the minimal lumen diameter for all lesions measured). Cumulative coronary stenosis score (calculated by adding all percent diameter stenoses in SI units). - Coronary OCT endpoints, assessed in a sub-population (see section 8.2.2.5), nominal changes from baseline to study end: Surface area of fibrous cap thickness | — |
Countries
Netherlands
Outcome results
None listed