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Clinical Trials List

Protocol NumberEFC11570
NCT Number(ClinicalTrials.gov Identfier)NCT01663402

2013-02-15 - 2018-09-30

Phase III

Terminated15

ICD-10I20.0

Unstable angina

ICD-9411.1

Intermediate coronary syndrome

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome

  • Trial Applicant

  • Sponsor

    Sanofi

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 翁國昌 Division of Cardiovascular Diseases
Chung Shan Medical University Hospital

Co-Principal Investigator

  • 蔡青峰 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 徐國基 Division of Cardiovascular Diseases
Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

  • 林申昌 Division of Cardiovascular Diseases
  • 蔡適吉 Division of Cardiovascular Diseases
  • 陳隆景 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 殷偉賢 Division of Cardiovascular Diseases
Cheng Hsin General Hospital

Co-Principal Investigator

  • 陳冠群 Division of Cardiovascular Diseases
  • 黃文彬 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Juey-Jen Hwang Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chern-En Chiang Division of Cardiovascular Diseases
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator I-Chang Hsieh Division of Cardiovascular Diseases
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 方志元 Division of Cardiovascular Diseases
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 夏建勳 Division of Cardiovascular Diseases
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 郭任遠 Division of Cardiovascular Diseases
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 劉銘恩 Division of Cardiovascular Diseases
Hsinchu Mackay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林維祥 Division of Cardiovascular Diseases
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 黃崔源 Division of Cardiovascular Diseases
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator WEN-TER Lai Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wei-Chuan Tsai Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

18 Terminated

Principal Investigator 郭任遠 Division of Cardiovascular Diseases
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Acute Coronary Syndrome

Objectives

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: 1.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). 2.To evaluate the safety and tolerability of alirocumab. 3.To evaluate the effect of alirocumab on lipid parameters.

Test Drug

SAR236553/REGN727

Active Ingredient

SAR236553

Dosage Form

Injection

Dosage

75mg / ml or 150mg /ml or placebo

Endpoints

Primary Outcome Measures:
1. Time to First Occurrence of Major Adverse Cardiovascular Event (MACE); Percentage of Observed Participants With Outcome Measure Events During the Study.

Secondary Outcome Measures:
1. Time to First Occurrence of Any Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study.
2. Time to First Occurrence of Any Major Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study.
3. Time to First Occurrence of Any Cardiovascular Event; Percentage of Observed Participants With Outcome Measure Events During the Study .
4. Time to First Occurrence of All-Cause Mortality, Non-Fatal Myocardial Infarction, Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study.
5. Time to Coronary Heart Disease Death; Percentage of Observed Participants With Outcome Measure Events During the Study.
6. Time to Cardiovascular Death; Percentage of Observed Participants With Outcome Measure Events During the Study.
7. Time to All-Cause Death; Percentage of Observed Participants With Outcome Measure Events During the Study.
8. Time to First Occurrence of Any Non-Fatal Myocardial Infarction; Percentage of Observed Participants With Outcome Measure Events During the Study.
9. Time to First Occurrence of Fatal or Any Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study.
10. Time to First Occurrence of Any Unstable Angina Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study.
11. Time to First Occurrence of Any Ischemia-Driven Coronary Revascularization Procedure; Percentage of Observed Participants With Outcome Measure Events During the Study.
12. Time to First Occurrence of Any Congestive Heart Failure (CHF) Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study.

Other Outcome Measures:
1. Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: ITT Analysis.
2. Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: On-Treatment Analysis.

Inclution Criteria

Recently (< 52 weeks) hospitalized for ACS.

Exclusion Criteria

AExclusion criteria:

Age < 40 years.
ACS event occurring more than 52 weeks prior to randomization visit.
LDL-C likely to be <70 mg/dL (<1.81 mmo/L), and apolipoprotein B (ApoB) <80 mg/dL (<0.8 g/L), and non - high-density lipoprotein cholesterol (HDL-C) <100 mg/dL (<2.59 mmol/L) with evidence-based medical and dietary management of dyslipidemia.

The Estimated Number of Participants

  • Taiwan

    286 participants

  • Global

    18000 participants

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