Hypercholesterolemia, Acute Coronary Syndromes
Conditions
Interventions
Consenting patients will be randomized into two arms. The intervention arm will receive SAR236553 - 75mg/150mg as a subcutaneous injection every two weeks until a study end-point is reached. It is exp
Sponsors
Sanofi-Aventis
Eligibility
Inclusion criteria
Inclusion criteria: 1. Recent acute coronary syndrome (4-16 weeks prior to randomization) 2. On intensive statin therapy (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of these given statins, or other non statin LMT(s). 3. 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 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). 4. Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. All of the following: LDL-C 180 mmHg or DBP > 110 mmHg) at V2 or V3. 6. 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. 9. Known history of untreated hypothyroidism. 10. Patient who has been previously treated with at least one dose of SAR236553 or any other anti-PCSK9 monoclonal antibody in other clinical trials. 11. Laboratory findings measured during screening and before randomization visit: Positive test for hepatitis B surface antigen and/or hepatitis C antibody, Triglycerides (TG) > 400mg/dL (>4.52 mmol/L) (1 repeat lab allowed), Positive serum or urine pregnancy test in females of childbearing potential, eGFR 3 x ULN on most recent determination prior to randomization (1 repeat lab is allowed), CPK >3 x ULN on most recent determination prior to randomization (1 repeat lab is allowed). 19. Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases, patients with short life expectancy. 20. Patients considered by the Investigator or any sub-Investigator as inappropriate for this study for any reason, eg: •Those deemed unable to meet specific protocol requirements, such as scheduled visits. •Investigator or any sub-Investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol, etc. •Presence of any other conditions (eg, geographic, social….) actual or anticipated, that the Investigator feels would restrict or limit the patient’s participation for the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CHD death [From randomization up to 64months] Any non-fatal MI [From randomization up to 64months] Fatal and non-fatal ischemic stroke [From randomization up to 64months] Unstable angina requiring hospitalization [From randomization up to 64months] | — |
Secondary
| Measure | Time frame |
|---|---|
| The first occurrence of any CHD event 2. 3. Any CV event, 4. , 5. [Every month up to completion 64 months post randomization] The first occurrence of Major CHD event [Every month up to completion 64 months post randomization] The first occurrence of Any CV event [Every month up to completion 64 months post randomization ] Composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke [Every month up to completion 64 months post randomization ] All cause mortality [Every month up to completion 64 months post randomization ] | — |
Countries
Argentina,Australia,Austria,Belarus,Belgium,Brazil,Bulgaria,Canada,Chile,Colombia,Czech Republic,Denmark,Estonia,Finland,France,Germany,Hong Kong,Hungary,India,Israel,Italy,Latvia,Lithuania,Malaysia,M
Contacts
Public ContactDr. Sepalika Mendis
Coordinating Principal Investigator and Consultant Cardiologist
Outcome results
None listed