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

What this Trial Is About

Researchers are evaluating the anti-platelet effects of berberine in patients who have undergone percutaneous coronary intervention (PCI) and are currently taking aspirin and clopidogrel. This randomized, open-label, controlled study involves about 64 patients between 18 and 70 years old who are between 8 and 40 weeks post-PCI. The study aims to explore how berberine might improve antiplatelet therapy, as current treatments have variable effects and risks of bleeding or thrombotic events. Participants are assigned to one of two groups. One group receives escalating doses of berberine (200 mg twice daily for 4 weeks, then 300 mg twice daily for 4 weeks, and finally 400 mg twice daily for 4 weeks) along with standard aspirin and clopidogrel treatment. The other group continues with standard treatment only. The total treatment period lasts approximately 12 weeks, followed by a 4-week safety follow-up. Study visits are scheduled at baseline, weeks 4, 8, 12, and 16 for dose adjustments, treatment assessments, and safety monitoring. During the study, blood and urine samples will be collected to assess platelet function and safety at various visits. Researchers will measure the P2Y12 reaction unit (PRU) as the primary outcome around week 12 of treatment. Secondary outcomes include other platelet reactivity measures and urinary biomarkers. Adverse events and cardiac or bleeding events will also be monitored. The total participation time for each patient is about 19 weeks, including screening and follow-up.

Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention