Berberine's effect on blood platelets in heart patients after surgery

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

This study is testing if adding berberine to the usual blood-thinning medications can help heart patients after surgery feel safer and reduce the risk of blood clots.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT03378934 on ClinicalTrials.gov

What this trial studies

This study investigates the anti-platelet effects of berberine in patients who have undergone percutaneous coronary intervention (PCI) and are currently on dual antiplatelet therapy with aspirin and clopidogrel. It is a single-center, randomized, open-label, controlled trial involving approximately 64 participants who are between 8 to 40 weeks post-PCI. The study aims to determine if adding berberine can enhance the effectiveness of the existing antiplatelet regimen without increasing bleeding risks. Participants will be monitored for thrombotic events and overall safety throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 who are between 8 to 40 weeks post-PCI and currently receiving dual antiplatelet therapy.

Not a fit: Patients who have experienced cardiac ischemic or bleeding events after their PCI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new approach to improve antiplatelet therapy and reduce thrombotic risks in patients after PCI.

How similar studies have performed: While there have been small studies on berberine's effects, this specific approach in the context of PCI is novel and has not been extensively tested.

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 and clopidogrel, within 30 days of screening.
3. 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.
4. 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.
5. 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.
6. Planned coronary revascularization, including PCI and coronary artery bypass graft (CABG) during the study period.
7. Increased bleeding risk, including

   * any history of intracranial, intraocular, retroperitoneal, or spinal bleeding;
   * recent (within 30 days of screening) gastrointestinal (GI) bleeding;
   * recent (within 30 days of screening) major trauma or major surgery;
   * planned surgery or other invasive procedure during the study period;
   * sustained uncontrolled hypertension (systolic blood pressure \[SBP\] \> 180 mmHg or diastolic blood pressure \[DBP\] \> 100 mmHg);
   * history of hemorrhagic disorders, e.g., haemophilia, von Willebrand's disease;
   * inability to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during the study period;
   * platelet count less than 100,000/mm3 or hemoglobin \< 10 g/dL.
8. 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.
9. History of intolerance to aspirin, clopidogrel, and berberine.
10. Any condition, which in the opinion of the Investigator, would make it unsuitable for the patient to participate in this study. For example, conditions which may put the patient at risk, e.g., liver or kidney dysfunction, et al; or increase the risk of non-compliance to study protocol or follow-up, e.g., history of drug addiction or alcohol abuse, et al; or influence the result of the study, e.g., active cancer, et al.
11. Patients who has previously been randomized in this study.
12. Participation in another investigational drug or device study within 30 days of screening.
13. Involvement in the planning and conduct of the study (applies to investigators, contract research organization staff, and study site staff, et al).

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Zhenyu Liu, M.D. — Department of Cardiology, Peking Union Medical College Hospital
• Study coordinator: Zhenyu Liu, M.D.

Conditions Coronary Artery Disease; Percutaneous Coronary Intervention; Antiplatelet; Berberine