Clinical Trials Logo

Clinical Trial Summary

Primary Objective:

To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia.

Secondary Objectives:

- To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality).

- To evaluate the safety and tolerability of alirocumab.

- To evaluate the effect of alirocumab on lipid parameters.


Clinical Trial Description

18924 number of participants aged >= 40 years old were randomized in the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01663402
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date October 2012
Completion date January 23, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT01572259 - Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism Phase 3
Completed NCT05792787 - Association Between Apical Periodontitis and Atherosclerotic Cardiovascular Diseases
Completed NCT03911284 - The Learning Registry
Recruiting NCT06048588 - YN001 in Healthy Subjects and Patients With Coronary Atherosclerosis Phase 1/Phase 2
Active, not recruiting NCT03705234 - A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease Phase 3
Completed NCT03096288 - Impact of Evolocumab on the Effects of Clopidogrel in Patients With High On-Treatment Platelet Reactivity Phase 4
Enrolling by invitation NCT05485961 - Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis Phase 2/Phase 3
Completed NCT03597412 - Rosuvastatin/Ezetimibe Versus Rosuvastatin in ASCVD Patients With Type 2 DM Phase 4
Completed NCT05974345 - In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease
Active, not recruiting NCT05030428 - Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease Phase 3
Completed NCT00185185 - Olmesartan Medoxomil in Atherosclerosis Phase 3
Completed NCT05129241 - Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector
Completed NCT02991118 - Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk Phase 3
Completed NCT05639244 - Time Restricted Eating and Innate Immunity N/A
Completed NCT02988115 - Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant Phase 3
Recruiting NCT04215237 - How Atorvastatin Affects the Gut Flora and Metabolomics? N/A
Completed NCT05355402 - A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia Phase 2
Recruiting NCT05726838 - The Belgian REAL (BE.REAL) Registry
Active, not recruiting NCT04462159 - The Young Heart Study N/A
Not yet recruiting NCT03505073 - Association Between Dietary Habits and Risk Factors for Atherosclerotic Cardiovascular Diseases in Assiut Governorate