HypercholesterolemiaPhase 4ODYSSEY J-IVUSNCT02984982
Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia
A Phase 4 study testing Alirocumab SAR236553, Atorvastatin and Rosuvastatin in people with Hypercholesterolemia and Acute Coronary Syndrome, run by Sanofi at 39 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypercholesterolemia, Acute Coronary Syndrome
- What is being tested?
- Alirocumab SAR236553, Atorvastatin and Rosuvastatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 39 sitesJapan
- Study dates
- 15 Nov 2016to 27 Jul 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
Japan39 sites
Investigational Site Number 392026
Bunkyō City
Investigational Site Number 392022
Chiyoda-ku
Investigational Site Number 392032
Fujisawa-shi
Investigational Site Number 392004
Fukui-shi
Investigational Site Number 392007
Fukuoka
Investigational Site Number 392048
Fukuoka
Investigational Site Number 392008
Gifu
Investigational Site Number 392039
Hiroshima
Investigational Site Number 392028
Isehara-shi
Investigational Site Number 392024
Izumisano
Investigational Site Number 392013
Izunokuni-shi
Investigational Site Number 392020
Kawaguchi-shi
Investigational Site Number 392009
Kitakyushu-shi
Investigational Site Number 392034
Kitakyushu-shi
Investigational Site Number 392044
Kochi
Investigational Site Number 392002
Kumamoto
Investigational Site Number 392011
Kumamoto
Investigational Site Number 392003
Kurashiki-shi
Investigational Site Number 392018
Matsuyama
Investigational Site Number 392021
Morioka
Investigational Site Number 392017
Nagakute-shi
Investigational Site Number 392047
Nagaoka-shi
Investigational Site Number 392033
Okayama
Investigational Site Number 392006
Osaka
Investigational Site Number 392010
Osaka
Investigational Site Number 392045
Osaka
Investigational Site Number 392046
Osaka
Investigational Site Number 392015
Sagamihara-shi
Investigational Site Number 392019
Sakaishi
Investigational Site Number 392035
Sapporo
Investigational Site Number 392036
tabashi City
Investigational Site Number 392037
tabashi City
Investigational Site Number 392001
Tenri-shi
Investigational Site Number 392016
Toyoake-shi
Investigational Site Number 392025
Tsukuba
Investigational Site Number 392040
Tsukuba
Investigational Site Number 392005
Wakayama
Investigational Site Number 392027
Yokohama
Investigational Site Number 392043
Yokohama
About this study
Official title: A Randomized, Open-label, Blinded Intravascular Ultrasound Analysis, Parallel Group, Multicenter Study to Evaluate the Effect of Praluent® (Alirocumab) on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia Not Adequately Controlled With Statin
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.
Read more
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.
Read the detailed description
The duration of study per participant was 9 months.
- Conditions
- Hypercholesterolemia, Acute Coronary Syndrome
- Being tested
- Alirocumab SAR236553, Atorvastatin, Rosuvastatin, Fenofibrate, Bezafibrate
- Medical subject headings
- Hypercholesterolemia, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alirocumab SAR236553Drug
Also called Praluent
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
AtorvastatinDrug
Pharmaceutical form: tablet
Route of administration: oral
RosuvastatinDrug
Pharmaceutical form: tablet
Route of administration: oral
FenofibrateDrug
Pharmaceutical form: tablet
Route of administration: oral
BezafibrateDrug
Pharmaceutical form: tablet
Route of administration: oral
EzetimibeDrug
Pharmaceutical form: tablet
Route of administration: oral
AntiplateletsDrug
Pharmaceutical form: tablet or capsule
Route of administration: oral
AnticoagulantsDrug
Pharmaceutical form: tablet or capsule
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Statin therapy (atorvastatin or rosuvastatin) will be administered with or without non-statin lipid modifying therapies (LMTs). Non-statin LMTs will be adjusted by physicians to achieve the LDL-C target level <100 milligrams per deciliter (mg/dL). Receives: Drug: Atorvastatin; Drug: Rosuvastatin; Drug: Fenofibrate; Drug: Bezafibrate; Drug: Ezetimibe; Drug: Antiplatelets; Drug: Anticoagulants |
| Alirocumab | Experimental | Alirocumab will be given subcutaneously every 2 weeks on top of stable dose statin therapy (atorvastatin or rosuvastatin) with or without stable dose non-statin LMTs. Receives: Drug: Alirocumab SAR236553; Drug: Atorvastatin; Drug: Rosuvastatin; Drug: Fenofibrate; Drug: Bezafibrate; Drug: Ezetimibe; Drug: Antiplatelets; Drug: Anticoagulants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36
Least-squares (LS) means and standard errors (SE) at Week 36 were obtained from analysis of covariance (ANCOVA) model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate.
Measured: Baseline, Week 36
Secondary outcomes (23)
Absolute Change From Baseline in Percent Atheroma Volume (PAV) at Week 36
LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline PAV as continuous fixed covariate.
Measured: Baseline, Week 36
Absolute Change From Baseline in Normalized Total Atheroma Volume at Week 36
LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate.
Measured: Baseline, Week 36
Absolute Change From Baseline in External Elastic Membrane (EEM) Volume at Week 36
Adjusted mean and SE at Week 36 were obtained from robust regression model with treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]), as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate.
Measured: Baseline, Week 36
Percent Change From Baseline in External Elastic Membrane Volume at Week 36
Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate.
Measured: Baseline, Week 36
Absolute Change From Baseline in Lumen Volume at Week 36
Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline lumen volume value as continuous fixed covariate.
Measured: Baseline, Week 36
Percent Change From Baseline in Lumen Volume at Week 36
Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and the baseline lumen volume value as continuous fixed covariate.
Measured: Baseline, Week 36
Absolute Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36
Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates.
Measured: Baseline, Week 12, Week 36
Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36
Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates.
Measured: Baseline, Week 12, Week 36
Absolute Change From Baseline in Apolipoprotein B (Apo B) at Week 36
Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate.
Measured: Baseline, Week 36
Percent Change From Baseline in Apolipoprotein B at Week 36
Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate.
Measured: Baseline, Week 36
Absolute Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 36
Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates.
Measured: Baseline, Week 36
Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol at Week 36
Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates.
Measured: Baseline, Week 36
Absolute Change From Baseline in Total Cholesterol (TC) at Week 36
LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated TC value and baseline calculated TC value-by-time point interaction as continuous fixed covariates.
Measured: Baseline, Week 36
Percent Change From Baseline in Total Cholesterol at Week 36
Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline TC value and baseline TC value-by-time point interaction as continuous fixed covariates.
Measured: Baseline, Week 36
Absolute Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 36
Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate.
Measured: Baseline, Week 36
Percent Change From Baseline in Lipoprotein (a) at Week 36
Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate.
Measured: Baseline, Week 36
Absolute Change From Baseline in High-density Lipoprotein Cholesterol at Week 36
Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates.
Measured: Baseline, Week 36
Percent Change From Baseline in High-density Lipoprotein Cholesterol at Week 36
Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates.
Measured: Baseline, Week 36
Absolute Change From Baseline in Fasting Triglycerides (TGs) at Week 36
Adjusted mean and SE were obtained from multiple imputation approach followed by robust regression model including fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) and the continuous fixed covariate of baseline fasting TGs value.
Measured: Baseline, Week 36
Percent Change From Baseline in Fasting Triglycerides at Week 36
Adjusted mean and SE were obtained by multiple imputation approach followed by robust regression model included fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) and the continuous fixed covariate of baseline fasting TGs value.
Measured: Baseline, Week 36
Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 36
Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate.
Measured: Baseline, Week 36
Percent Change From Baseline in Apolipoprotein A-1 at Week 36
Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate.
Measured: Baseline, Week 36
Number of Participants With Cardiovascular (CV) Adverse Events
The suspected or confirmed CV events that occurred from randomization until end of the study visit were collected and reported. The various CV events included CV death, myocardial infarction, ischemic stroke, unstable angina requiring hospitalization , congestive heart failure requiring hospitalization, congestive heart failure requiring hospitalization, ischemia-driven coronary revascularization procedure.
Measured: Up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start15 Nov 2016
- Primary completion27 Jul 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984982
- Sponsor's protocol ID
- ALIROL08069
- Other IDs
- U1111-1184-8764
- Acronym
- ODYSSEY J-IVUS
- Status last verified
- Jul 2019
- First submitted
- 5 Dec 2016
- Last updated
- 9 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not available for request.
Publications
Ako J, Hibi K, Tsujita K, Hiro T, Morino Y, Kozuma K, Shinke T, Otake H, Uno K, Louie MJ, Takagi Y, Miyauchi K. Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients With Acute Coronary Syndrome - The ODYSSEY J-IVUS Trial. Circ J. 2019 Sep 25;83(10):2025-2033. doi: 10.1253/circj.CJ-19-0412. Epub 2019 Aug 20.
PubMed 31434809Ako J, Hibi K, Kozuma K, Miyauchi K, Morino Y, Shinke T, Tsujita K, Uno K, Kawabata Y, Hiro T. Effect of alirocumab on coronary atheroma volume in Japanese patients with acute coronary syndromes and hypercholesterolemia not adequately controlled with statins: ODYSSEY J-IVUS rationale and design. J Cardiol. 2018 Jun;71(6):583-589. doi: 10.1016/j.jjcc.2017.11.013. Epub 2018 Mar 30.
PubMed 29606415
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Blinded Intravascular Ultrasound Analysis, Parallel Group, Multicenter Study to Evaluate the Effect of Praluent® (Alirocumab) on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia Not Adequately Controlled With Statin
- ClinicalTrials.gov ID
- NCT02984982
- Acronym / sponsor ID
- ODYSSEY J-IVUS / ALIROL08069
- Conditions
- Hypercholesterolemia, Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Posted 9 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The duration of study per participant was 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: Atorvastatin, Drug: Rosuvastatin, Drug: Fenofibrate, Drug: Bezafibrate, Drug: Ezetimibe, Drug: Antiplatelets, Drug: AnticoagulantsStatin therapy (atorvastatin or rosuvastatin) will be administered with or without non-statin lipid modifying therapies (LMTs). Non-statin LMTs will be adjusted by physicians to achieve the LDL-C target level <100 milligrams per deciliter (mg/dL). |
| Alirocumab | Experimental | Drug: Alirocumab SAR236553, Drug: Atorvastatin, Drug: Rosuvastatin, Drug: Fenofibrate, Drug: Bezafibrate, Drug: Ezetimibe, Drug: Antiplatelets, Drug: AnticoagulantsAlirocumab will be given subcutaneously every 2 weeks on top of stable dose statin therapy (atorvastatin or rosuvastatin) with or without stable dose non-statin LMTs. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alirocumab SAR236553Also: PraluentPharmaceutical form: Solution for injection Route of administration: Subcutaneous | Drug | Alirocumab |
| AtorvastatinPharmaceutical form: tablet Route of administration: oral | Drug | Alirocumab, Standard of Care |
| RosuvastatinPharmaceutical form: tablet Route of administration: oral | Drug | Alirocumab, Standard of Care |
| FenofibratePharmaceutical form: tablet Route of administration: oral | Drug | Alirocumab, Standard of Care |
| BezafibratePharmaceutical form: tablet Route of administration: oral | Drug | Alirocumab, Standard of Care |
| EzetimibePharmaceutical form: tablet Route of administration: oral | Drug | Alirocumab, Standard of Care |
| AntiplateletsPharmaceutical form: tablet or capsule Route of administration: oral | Drug | Alirocumab, Standard of Care |
| AnticoagulantsPharmaceutical form: tablet or capsule Route of administration: oral | Drug | Alirocumab, Standard of Care |
Primary outcome
Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36
Time frame: Baseline, Week 36
Least-squares (LS) means and standard errors (SE) at Week 36 were obtained from analysis of covariance (ANCOVA) model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate.
23 secondary outcomes
Absolute Change From Baseline in Percent Atheroma Volume (PAV) at Week 36
Time frame: Baseline, Week 36
Absolute Change From Baseline in Normalized Total Atheroma Volume at Week 36
Time frame: Baseline, Week 36
Absolute Change From Baseline in External Elastic Membrane (EEM) Volume at Week 36
Time frame: Baseline, Week 36
Percent Change From Baseline in External Elastic Membrane Volume at Week 36
Time frame: Baseline, Week 36
Absolute Change From Baseline in Lumen Volume at Week 36
Time frame: Baseline, Week 36
Percent Change From Baseline in Lumen Volume at Week 36
Time frame: Baseline, Week 36
Absolute Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36
Time frame: Baseline, Week 12, Week 36
Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36
Time frame: Baseline, Week 12, Week 36
Absolute Change From Baseline in Apolipoprotein B (Apo B) at Week 36
Time frame: Baseline, Week 36
Percent Change From Baseline in Apolipoprotein B at Week 36
Time frame: Baseline, Week 36
Absolute Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 36
Time frame: Baseline, Week 36
Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol at Week 36
Time frame: Baseline, Week 36
Absolute Change From Baseline in Total Cholesterol (TC) at Week 36
Time frame: Baseline, Week 36
Percent Change From Baseline in Total Cholesterol at Week 36
Time frame: Baseline, Week 36
Absolute Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 36
Time frame: Baseline, Week 36
Percent Change From Baseline in Lipoprotein (a) at Week 36
Time frame: Baseline, Week 36
Absolute Change From Baseline in High-density Lipoprotein Cholesterol at Week 36
Time frame: Baseline, Week 36
Percent Change From Baseline in High-density Lipoprotein Cholesterol at Week 36
Time frame: Baseline, Week 36
Absolute Change From Baseline in Fasting Triglycerides (TGs) at Week 36
Time frame: Baseline, Week 36
Percent Change From Baseline in Fasting Triglycerides at Week 36
Time frame: Baseline, Week 36
Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 36
Time frame: Baseline, Week 36
Percent Change From Baseline in Apolipoprotein A-1 at Week 36
Time frame: Baseline, Week 36
Number of Participants With Cardiovascular (CV) Adverse Events
Time frame: Up to 36 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31434809Ako J, Hibi K, Tsujita K, Hiro T, Morino Y, Kozuma K, Shinke T, Otake H, Uno K, Louie MJ, Takagi Y, Miyauchi K. Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients With Acute Coronary Syndrome - The ODYSSEY J-IVUS Trial. Circ J. 2019 Sep 25;83(10):2025-2033. doi: 10.1253/circj.CJ-19-0412. Epub 2019 Aug 20.
- Derived from this study: PubMed 29606415Ako J, Hibi K, Kozuma K, Miyauchi K, Morino Y, Shinke T, Tsujita K, Uno K, Kawabata Y, Hiro T. Effect of alirocumab on coronary atheroma volume in Japanese patients with acute coronary syndromes and hypercholesterolemia not adequately controlled with statins: ODYSSEY J-IVUS rationale and design. J Cardiol. 2018 Jun;71(6):583-589. doi: 10.1016/j.jjcc.2017.11.013. Epub 2018 Mar 30.
- Individual participant dataSharing planned: No. Not available for request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alirocumab SAR236553, Atorvastatin and Rosuvastatin in people with Hypercholesterolemia and Acute Coronary Syndrome, run by Sanofi at 39 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36 (time frame: Baseline, Week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02984982, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.