Ignite Creation Date:
2024-05-06 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02984982
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2016-12-05
Brief Title:
Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ODYSSEY J-IVUS
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1184-8764 | OTHER | UTN | None |