Phase 4
N=206
Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia
Hypercholesterolemia · Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02984982 ↗Enrolled (actual)
206
Serious AEs
17.6%
Results posted
Sep 2019
Primary outcome: Primary: Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36 — -3.14; -4.79 percent change — p=0.2279
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Alirocumab SAR236553 (Drug); Atorvastatin (Drug); Rosuvastatin (Drug); Fenofibrate (Drug); Bezafibrate (Drug); Ezetimibe (Drug); Antiplatelets (Drug); Anticoagulants (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36 |
-3.14; -4.79 | 0.2279 |
| SECONDARY Absolute Change From Baseline in Percent Atheroma Volume (PAV) at Week 36 |
-1.28; -1.42 | — |
| SECONDARY Absolute Change From Baseline in Normalized Total Atheroma Volume at Week 36 |
-4.73; -5.77 | — |
| SECONDARY Absolute Change From Baseline in External Elastic Membrane (EEM) Volume at Week 36 |
-8.23; -10.01 | — |
| SECONDARY Percent Change From Baseline in External Elastic Membrane Volume at Week 36 |
-0.86; -3.18 | — |
| SECONDARY Absolute Change From Baseline in Lumen Volume at Week 36 |
-1.25; -0.93 | — |
| SECONDARY Percent Change From Baseline in Lumen Volume at Week 36 |
1.20; -0.86 | — |
| SECONDARY Absolute Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36 |
-9.6; -62.4; -15.5; -63.2 | — |
| SECONDARY Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36 |
-7.57; -64.53; -13.40; -63.94 | — |
| SECONDARY Absolute Change From Baseline in Apolipoprotein B (Apo B) at Week 36 |
-16.8; -51.0 | — |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 36 |
-16.61; -55.13 | — |
| SECONDARY Absolute Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 36 |
-20.3; -69.2 | — |
| SECONDARY Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol at Week 36 |
-14.06; -54.50 | — |
| SECONDARY Absolute Change From Baseline in Total Cholesterol (TC) at Week 36 |
-15.2; -61.7 | — |
| SECONDARY Percent Change From Baseline in Total Cholesterol at Week 36 |
-7.59; -35.43 | — |
| SECONDARY Absolute Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 36 |
-10.3; -15.5 | — |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) at Week 36 |
-17.23; -55.76 | — |
| SECONDARY Absolute Change From Baseline in High-density Lipoprotein Cholesterol at Week 36 |
4.7; 8.1 | — |
| SECONDARY Percent Change From Baseline in High-density Lipoprotein Cholesterol at Week 36 |
12.19; 21.04 | — |
| SECONDARY Absolute Change From Baseline in Fasting Triglycerides (TGs) at Week 36 |
-26.2; -35.3 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 36 |
-8.85; -18.37 | — |
| SECONDARY Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 36 |
3.8; 12.0 | — |
| SECONDARY Percent Change From Baseline in Apolipoprotein A-1 at Week 36 |
4.61; 11.75 | — |
| SECONDARY Number of Participants With Cardiovascular (CV) Adverse Events |
0; 0; 3; 2; 0; 2 | — |
Summary
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 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.
Data sourced from ClinicalTrials.gov (NCT02984982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.