A STUDY TO EVALUATE THE EFFECT OF SAR236553/REGN727 ON THE OCCURRENCE OF CARDIOVASCULAR EVENTS IN PATIENTS WHO HAVE RECENTLY EXPERIENCED AN ACUTE CORONARY SYNDROME

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-026-13

Enrollment

208

Registered

2013-10-02

Start date

2013-10-15

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Formulation: Sterile SAR236553drug product supplied at a concentration of 75 mg/mL or 150 mg/mL in 10 mM histidine, pH 6.0, 0.01% (w/v) polysorbate 20, and 10% (w/v) sucrose. Route(s) of administratio

Eligibility

Sex/Gender

All

Age

40 Years to 100 Years

Inclusion criteria

Inclusion criteria: • 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).

Exclusion criteria

Exclusion criteria: • All of the following: LDL-C 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 400 mg/dL (>4.52 mmol/L) prior to randomization.

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, India, Lithuania, Malasya, Mexico, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United States

Contacts

Public ContactKatia Lourdes Meza

SANOFI AVENTIS DEL PERU S.A.

Katia.Meza-ext@sanofi.com995872601

Outcome results