Actively Recruiting
Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention
Led by Peking Union Medical College Hospital · Updated on 2025-11-19
64
Participants Needed
1
Research Sites
409 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent.
- Aged between 18 and 70 years, male or female.
- More than 8 but less than or equal to 40 weeks after percutaneous coronary intervention (PCI).
- Receiving dual antiplatelet therapy with aspirin 100 mg once daily and clopidogrel 75 mg once daily for at least 7 days.
- No cardiac ischemic or bleeding events after the PCI.
- PRECISE-DAPT score less than 25 after PCI and before hospital discharge.
- Females must be post-menopausal for over 1 year or surgically sterile.
You will not qualify if you...
- Use of berberine within 30 days before screening.
- Use of any fibrinolytic or antithrombotic agents other than aspirin and clopidogrel within 30 days before screening.
- Fibrinolytic or antithrombotic treatment for reasons other than coronary artery disease.
- Planned use of berberine or other fibrinolytic or antithrombotic agents except aspirin and clopidogrel during the study.
- Planned use of moderate or strong CYP2C19 inhibitors, narrow therapeutic index CYP2C19 substrates, or strong CYP2C19 inducers during the study.
- Planned coronary revascularization including PCI or coronary artery bypass graft during the study.
- Increased bleeding risk including history of intracranial, intraocular, retroperitoneal, or spinal bleeding; recent gastrointestinal bleeding; recent major trauma or surgery; planned surgery or invasive procedures; uncontrolled hypertension; bleeding disorders; inability to stop NSAIDs; low platelet count or low hemoglobin.
- Contraindications or intolerance to aspirin, clopidogrel, or berberine.
- Conditions that make participation unsuitable, such as liver or kidney dysfunction, history of addiction or alcohol abuse, active cancer.
- Previous randomization in this study.
- Participation in another investigational drug or device study within 30 days before screening.
- Involvement in planning or conduct of this study.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Z
Zhenyu Liu, M.D.
CONTACT
L
Lihong Xu, B.N.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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