A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFECT OF SAR236553/REGN727 ON THE OCCURRENCE OF CARDIOVASCULAR EVENTS IN PATIENTS WHO HAVE RECENTLY EXPERIENCED AN ACUTE CORONARY SYNDROME

sanofi-aventis Recherche & Development,0 个研究点目标入组 220 人开始时间: 2013年10月2日最近更新: 2023年9月4日

适应症

试验速览

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•Hospitalization for ACS defined by:
•- Ischemic symptoms with unstable pattern, occurring at rest or minimal exertion within 24 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.
•Patients not adequately controlled (as defined by at least one of the following: LDL-C ≥70 mg/dL [≥1.81 mmol/L], ApoB ≥80 mg/dL
•[≥0.8 mmol/L], or non-HDL-C ≥ 100 mg/dL [≥2.59 mmol/L]) at the qualifying Visit (V2), 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).

•All of the following: LDL-C <70 mg/dL (<1.81 mmol/L), ApoB < 80 mg/dL (< 0.8 mmol/L), and non-HDL-C <100 mg/dL (<2.59 mmol/L) at the
•qualifying Visit (V2).
•Age <40 years.
•Patients who have experienced an ACS event more than 16 weeks (+ 3 days) prior to randomization visit (V3).
•Not on a stable dose of atorvastatin or rosuvastatin for at least 2 weeks prior to qualifying visit (V2 or V2b) and at least 4 weeks prior to
•randomization visit (V3), or not on a stable dose of any other authorized LMT for at least 4 weeks prior to qualifying visit (V2 r V2b) and at least 6 weeks prior to randomization visit (V3, Month 0).
•Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg) at V2 or V3.
•New York Heart Association Class III or IV congestive heart failure persisting despite treatment or if measured LVEF <25%.
•Known history of hemorrhagic stroke.
•Fasting serum triglycerides (TG) >400 mg/dL (>4.52 mmol/L) prior to randomization.

发起方

sanofi-aventis Recherche & Development,