Last reviewed · How we verify
A Single-center, Randomized, Open-label, Controlled, Dose-escalating, Parallel-group Study to Assess the Anti-platelet Effect of Berberine in Patients Receiving Aspirin and Clopidogrel After Percutaneous Coronary Intervention (APLABE-PCI)
The APLABE-PCI is a single-center, randomized, open-label, controlled, dose-escalating, parallel-group study, which is designed to assess the anti-platelet effect of berberine in approximately 64 patients receiving aspirin and clopidogrel who are at \> 8 but ≤ 40 weeks after percutaneous coronary intervention.
Details
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | Phase 4 |
| Status | RECRUITING |
| Enrolment | 64 |
| Start date | 2018-09-26 |
| Completion | 2026-08 |
Conditions
- Coronary Artery Disease
- Percutaneous Coronary Intervention
Interventions
- Berberine
- Standard treatment
- Aspirin
- Clopidogrel
Primary outcomes
- P2Y12 reaction unit (PRU) — On the 12th (11th-13th) week of treatment
The P2Y12 reaction unit (PRU) assessed by VerifyNow assay 2-4 h after all the antiplatelet agents are taken simultaneously in the morning at the end of the treatment period (Visit 4, EOT), i.e., on the 12th (11th-13th) week of treatment
Countries
China