drugset / Trial / NCT06096909
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Not yet recruiting
3684 enrolled
China National Center for Cardiovascular Diseases
Innovent Biologics, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
For patients with ACS undergoing PCI, intensive lipid-lowering including PCSK9 monoclonal antibody should be started as soon as possible, that is, lower LDL-C level should be achieved as soon as possible. Compared with conventional lipid-lowering regimen, it is expected that the occurrence of major adverse cardiovascular events can still be reduced after drug discontinuation. Therefore, the optimization strategy of "for patients with ACS undergoing PCI, intensive lipid-lowering with PCSK9 monoclonal antibody can be started as soon as possible" is proposed.
Timeline
- Start
- 2023-11-01
- Primary completion
- 2025-11-01
- Completion
- 2027-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tafolecimab | Monoclonal antibody | 150 mg | Subcutaneous |
| Background | Atorvastatin | Small molecule | 20 mg | — |
| Comparator | Ezetimibe | Unknown | 10 mg | — |
| Comparator | HYZETIMIBE | Small molecule | — | — |
| Background | Pitavastatin | Small molecule | 4 mg | — |
| Background | Rosuvastatin | Small molecule | 10 mg | — |