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Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia
Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia

NCT02984982

CompletedPhase 4

Sponsor: Sanofi

Conditions: Hypercholesterolemia, Acute Coronary Syndrome

Interventions: Alirocumab SAR236553, Atorvastatin, Rosuvastatin, Fenofibrate, Bezafibrate

Countries: Japan

Primary Objective: To compare the efficacy of alirocumab (Praluent®) with standard of care (SoC) on coronary atheroma progression (percent change in normalized total atheroma volume \[TAV\]) after 9 months of treatment in participants who had acute coronary syndrome (ACS) within 4 weeks prior to randomization, with hypercholesterolemia treated with statin. Secondary Objectives: * To compare the efficacy of alirocumab (Praluent®) with SoC on secondary endpoints including absolute change in percent atheroma volume and normalized TAV after 9 months of treatment. * To evaluate the efficacy of alirocumab (Praluent®) on low-density lipoprotein cholesterol (LDL-C), apolipoprotein B, triglycerides, non-high-density lipoprotein cholesterol and lipoprotein (a) after 9 months treatment. * To evaluate the safety of alirocumab (Praluent®) including the occurrence of cardiovascular events (coronary heart disease death, non-fatal myocardial infarction, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) throughout the study.

Eligibility overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria :

* Participants hospitalized for ACS (Acute ST-segment elevation myocardial infarction \[STEMI\], Acute non-ST-segment elevation myocardial infarction \[NSTEMI\], and unstable angina.
* LDL-C \>=100 mg/dL at ACS diagnosis.
* Participants who has stenosis with at least \>50% stenosis angiographically within 1 week after the ACS onset, and has analyzable coronary intravascular Ultrasound image.
* Participants aged \>=20 years old at ACS diagnosis.
* Negative Hepatitis B surface antigen, negative Hepatitis B core antibody, and negative Hepatitis C antibody. Or, negative Hepatitis B surface antigen, positive Hepatitis B core antibody, negative Hepatitis B deoxyribonucleic acid, and negative Hepatitis C antibody.
* Written informed consent.

Exclusion criteria:

* Participants who had previously treated with at least one dose of any anti-proprotein convertase subtilisin/kexin type 9 monoclonal antibody.
* Uncontrolled hypertension (multiple reading with systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg) between ACS diagnosis and randomization visit.
* Known history of hemorrhagic stroke.
* Currently under treatment for cancer.
* Participants on LDL apheresis.
* Any clinically significant abnormality identified 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, participants with short life expectancy.
* Considered by the Investigator or any sub-Investigator as inappropriate for this study for any reason, including:

  * 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, etc.) actual or anticipated, that the Investigator feels would restrict or limit the participant's participation for the duration of the study.
* Laboratory findings measured within 4 weeks after the ACS diagnosis (positive serum or urine pregnancy test in females of childbearing potential).

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Locations (39)
  • Bunkyō City, Japan
  • Chiyoda-ku, Japan
  • Fujisawa-shi, Japan
  • Fukui-shi, Japan
  • Fukuoka, Japan
  • Fukuoka, Japan
  • Gifu, Japan
  • Hiroshima, Japan
  • Isehara-shi, Japan
  • Itabashi-ku, Japan
  • Itabashi-ku, Japan
  • Izumisano, Japan
  • Izunokuni-shi, Japan
  • Kawaguchi-shi, Japan
  • Kitakyushu-shi, Japan
  • Kitakyushu-shi, Japan
  • Kochi, Japan
  • Kumamoto, Japan
  • Kumamoto, Japan
  • Kurashiki-shi, Japan
  • Matsuyama, Japan
  • Morioka, Japan
  • Nagakute-shi, Japan
  • Nagaoka-shi, Japan
  • Okayama, Japan
  • Osaka, Japan
  • Osaka, Japan
  • Osaka, Japan
  • Osaka, Japan
  • Sagamihara-shi, Japan
  • + 9 more on CT.gov