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

Q: What is the NCT03378934 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

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

Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention (NCT03378934) is a Phase 4 interventional studying Coronary Artery Disease and Percutaneous Coronary Intervention, sponsored by Peking Union Medical College Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 64 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Coronary Artery Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Inclusion criteria 1. Provision of written willing to sign a consent form. 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

DRUG

Berberine

Berberine 200 mg twice daily for 4±1 weeks (Stage 1); then, 300 mg twice daily for 4±1 weeks (Stage 2); then, 400 mg twice daily for 4 weeks (Stage 3).

DRUG

Standard treatment

Standard treatment for 12±1 weeks.

DRUG

Aspirin

Aspirin 100 mg once daily for 12±1 weeks.

DRUG

Clopidogrel

Clopidogrel 75 mg once daily for 12±1 weeks.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT03378934), the sponsor (Peking Union Medical College Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT03378934 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT03378934?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT03378934?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT03378934. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT03378934. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.