drugset / Trial / NCT05457582
PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With ACS After PCI
Recruiting
1212 enrolled
Nanjing First Hospital, Nanjing Medical University
Nanjing Medical University · collabNational Natural Science Foundation of China · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The primary objective was to evaluate the effect of PCSK 9 Inhibitor (initiated within 4 h from PCI for the culprit lesion) with high-intensity statin treatment, compared to placebo with high-intensity statin treatment, on cardiovascular events (including cardiovascular death, myocardial infarction, stroke, re-hospitalization due to acute coronary syndromes or heart failure, or any ischemia-driven coronary revascularization) in patients with acute coronary syndrome and multiple lesions. Alirocumab was used before June 10, 2025; Tafolecimab has been used from June 10, 2025 onward.
Timeline
- Start
- 2023-03-30
- Primary completion
- 2026-09-30
- Completion
- 2030-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alirocumab | Monoclonal antibody | — | Subcutaneous |
| Comparator | Tafolecimab | Monoclonal antibody | — | Subcutaneous |
| Comparator | Rosuvastatin | Small molecule | 20 mg | Oral |