NCT03378934 Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention
| NCT ID | NCT03378934 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2018-09-26 |
| Primary Completion | 2026-06 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion criteria 1. Provision of written informed consent. 2. Aged 18-70 years, male or female. 3. Currently, \> 8 but ≤ 40 weeks after index percutaneous coronary intervention (PCI) . 4. Receiving dual antiplatelet therapy (DAPT) with aspirin (Bayaspirin TM) 100 mg once daily and clopidogrel (Plavix TM) 75 mg once daily for ≥ 7 days. 5. No cardiac ischemic events or bleeding events occurred after the index PCI. * Cardiac ischemic events include myocardial infarction, coronary revascularization, and definite or probable stent thrombosis; * Bleeding events include major or minor bleeding according to the Platelet Inhibition and Patient Outcomes (PLATO) definition. 6. PRECISE-DAPT score \< 25 evaluated after the index PCI and before the index hospital discharge. 7. Females who are either post-menopausal \> 1 year or surgically sterile. Exclusion criteria 1. Use of berberine within 30 days of screening. 2. Use of any fibrinolytic or antithrombotic agents, with the exception of aspirin a