ODYSSEY OUTCOME STUDY - 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

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Updated on 25 March 2021
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Summary

ODYSSEY OUTCOME STUDY - 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

Description

This study is looking at investigational drug, SAR236553, in patients who experienced a coronary event. One of the main risk factors for developing coronary heart disease is high levels of cholesterol in the blood, in particular high levels of a particular type of cholesterol called LDL-cholesterol (bad cholesterol). SAR236553 is an antibody (a type of protein) that binds a substance called PCSK9. The substance PCSK9 is secreted from the liver into the blood and increases LDL-cholesterol levels in the blood. Therefore, blocking PCSK9 through the use of the study drug can potentially decrease the blood LDL-cholesterol (bad cholesterol) levels of patients with high blood cholesterol.

Large studies conducted with statins have shown that lowering the blood cholesterol level, and more particularly the LDL-cholesterol, reduces the risk of cardiovascular events. The purpose of this study is to determine whether the study drug might prevent future cardiovascular events (such as, heart attacks or strokes) in qualifying patients. The study will compare the study drug versus a placebo injection on the occurrence of future cardiovascular events such as heart attack and stroke, when given in addition to the standard of care for lowering cholesterol.

Details
Condition Cardiovascular Abnormalities
Clinical Study IdentifierTX137600
Last Modified on25 March 2021

Eligibility

 Yes No Not Sure

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
elevated cardiac biomarkers OR
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)
AND OTHERS

Exclusion Criteria

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 or 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%
AND OTHERS
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