Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372925
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Brief Title:
Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Multi-Center Randomized Open-label Parallel Controlled Phase Ⅳ Clinical Trial to Evaluate the Effect of Inclisiran on Coronary Atherosclerotic Plaque in Patients With Acute Myocardial Infarction and Elevated Low-density Lipoprotein Cholesterol
Status:
RECRUITING
Status Verified Date:
2024-09
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:
V-ACCELERATE
Brief Summary:
This study is to evaluate the effect of Inclisiran on coronary atherosclerosis using intravascular ultrasound IVUS and optical coherence tomography OCT in patients with acute myocardial infarction and elevated low-density lipoprotein cholesterol LDL-C
Detailed Description:
This study will be a multi-center randomized parallel-group open-label phase 4 study Participants will be approximately 318 Chinese adults diagnosed with new-onset STEMINSTEMI and elevated LDL-C LDL-C 18 mmolL if on stable dose of statin with or without ezetimibe for 4 weeks LDL-C 26 mmolL if not on stable dose of statin with or without ezetimibe for 4 weeks Participants will be 11 randomized to investigational group Inclisiran 284mg 20mg atorvastatin or control group 20mg atorvastatin for 360 days Participants and investigator will be unblinded to the identity of the treatment from the time of randomization Independent Review Committee IRC staff performing the study assessments IVUS and OCT analysis will be blinded to the identity of the treatment from the time of randomization until final database lock
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CKJX839A1CN04 | OTHER | Novartis | None |