Can a natural compound help heart patients on blood thinners?
NCT ID NCT03378934
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding berberine, a natural compound, can improve blood thinning in heart patients who already take aspirin and clopidogrel after a stent procedure. About 64 adults will receive either standard treatment or berberine at increasing doses for 12 weeks. The goal is to see if berberine helps prevent blood clots better than standard care alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- berberine
- What this could lead to
- If it works, this could point toward a way to boost the effectiveness of standard blood thinners after heart stent surgery.
- What could go wrong
- This is a small, early-phase trial with only 64 participants, so results may not apply to everyone. Berberine might also cause side effects or interact with other medications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2018
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital
RECRUITINGBeijing, Beijing Municipality, 100730, China
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