Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention (NCT03378934) | Clinical Trial Compass
RecruitingPhase 4
Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention
China64 participantsStarted 2018-09-26
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. Use of berberine within 30 days of screening.
✕. Use of any fibrinolytic or antithrombotic agents, with the exception of aspirin and clopidogrel, within 30 days of screening.
✕. Any indications other than coronary artery disease (e.g., atrial fibrillation, prosthetic heart valve, venous thromboembolism, ventricular thrombosis, et al) for fibrinolytic or antithrombotic treatment during the study period.
✕. Planned use of berberine, as well as any fibrinolytic or antithrombotic agents, with the exception of aspirin (Bayaspirin TM) and clopidogrel (Plavix TM), during the study period.
✕
What they're measuring
1
P2Y12 reaction unit (PRU)
Timeframe: On the 12th (11th-13th) week of treatment
. Planned use of moderate or strong cytochrome P450 (CYP) 2C19 inhibitors, CYP2C19 substrates with narrow therapeutic index, or strong CYP2C19 inducers during the study period.
✕. Planned coronary revascularization, including PCI and coronary artery bypass graft (CABG) during the study period.
✕. Increased bleeding risk, including
✕. Contraindications for aspirin, clopidogrel, and berberine, e.g., hypersensitivity, active bleeding, bleeding diathesis, coagulation disorders, severe liver or kidney diseases, hemolytic anemia, glucose-6-phosphate dehydrogenase deficiency, et al.