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
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.
• Provision of written informed consent.
• Aged 18-70 years, male or female.
• Currently, \> 8 but ≤ 40 weeks after index percutaneous coronary intervention (PCI) .
• Receiving dual antiplatelet therapy (DAPT) with aspirin (Bayaspirin TM) 100 mg once daily and clopidogrel (Plavix TM) 75 mg once daily for ≥ 7 days.
• 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.
• PRECISE-DAPT score \< 25 evaluated after the index PCI and before the index hospital discharge.
• Females who are either post-menopausal \> 1 year or surgically sterile.