Cardiovascular events - Acute Coronary Syndrome
Conditions
Interventions
Treatment with SAR236553 or placebo
Sponsors
Sanofi BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Hospitalization for ACS (ST-elevation MI, non-ST elevation MI or high-risk unstable angina) defined by: - Ischemic symptoms with unstable pattern, occurring at rest or minimal exertion within 72 hrs of an unscheduled hospital admission, due to presumed or proven obstructive coronary disease AND at least one of the following: o Elevated cardiac biomarkers, OR o Resting ECG changes consistent with ischemia or infarction AND additional evidence of obstructive coronary disease;Patient lipid levels not adequately controlled at V2 (qualifying visit), despite evidence-based lipid lowering therapy (including intensive atorvastatin/rosuvastatin therapy or maximally tolerated dose of either of these 2 statins), or other non-statin LMTs. Inadequate lipid control means that patient must meet at least one of the following criteria at V2 to qualify: - LDL-C * 70 mg/dL (*1.81 mmol/L), or - ApoB * 80 mg/dL (* 0.8 g/L), or non-HDL-C * 100 mg/dL (*2.59 mmol/L)
Exclusion criteria
Exclusion criteria: All of the 3 following criteria are concomitantly present at the qualifying visit (V2): - LDL-C 180 mmHg or DBP > 110 mmHg) at V3 * New York Heart Association Class III or IV congestive heart failure persisting despite treatment or if measured LVEF 400 mg/dL (>4.52 mmol/L) prior to randomization * New ACS event occurring within 2 weeks prior to the randomization Visit (V3);Coronary revascularization (PCI or CABG) planned after randomization and/or performed within 2 weeks prior to the randomization Visit (V3)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint * Time from randomization to first occurrence of one of the following Clinical Events, as determined by the CEC: - CHD death. - Any non-fatal MI. - Fatal and non-fatal ischemic stroke. - Unstable angina requiring hospitalization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Main Secondary Efficacy Endpoint(s): * Time from randomization to first occurrence of any CHD event (major CHD event, unstable angina requiring hospitalization, hospitalization for unanticipated coronary revascularization procedure). * Time from randomization to first occurrence of any major CHD event (CHD death, non-fatal MI). * Time from randomization to first occurrence of any CV event defined as follows: any non-fatal CHD event, any CV death, and non-fatal ischemic stroke. * Time from randomization to first occurrence of all cause mortality, nonfatal MI, non-fatal ischemic stroke. * Time from randomization to death (all cause mortality). Other Secondary Efficacy Endpoint(s): * Components of the primary end point considered individually: CHD death, or non-fatal MI, or fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization. * Hospitalization for unanticipated coronary revascularization procedure. * Congestive heart failure requiring hospitalization. Safety Endpoint(s): * Safety endpoints: all adverse events, heart rate and blood pressure, hematology and biochemistry assessments. Other Endpoint(s): * Anti-SAR236553 antibodies assessed throughout the study. * The percent change in calculated LDL-C, in ApoB and non HDL-C. | — |
Countries
Netherlands
Outcome results
None listed