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

NCT03378934 | Recruiting Phase 4

• 2 other identifiers: 2016-I2M-1-011JS-1375
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Percutaneous Coronary Intervention

Keywords

Coronary Artery Disease; Percutaneous Coronary Intervention; Antiplatelet; Berberine

Outcome Measures

Primary Outcomes (1)

• P2Y12 reaction unit (PRU)

  The P2Y12 reaction unit (PRU) assessed by VerifyNow assay 2-4 h after all the antiplatelet agents are taken simultaneously in the morning at the end of the treatment period (Visit 4, EOT), i.e., on the 12th (11th-13th) week of treatment

  On the 12th (11th-13th) week of treatment

Secondary Outcomes (8)

• P2Y12 reaction unit (PRU)

  On the 8th (7th-9th) week of treatment

• P2Y12 reaction unit (PRU)

  On the 4th (3rd-5th) week of treatment

• Platelet reactivity index (PRI)

  On the 12th (11th-13th) week of treatment

• Platelet reactivity index (PRI)

  On the 8th (7th-9th) week of treatment

• Platelet reactivity index (PRI)

  On the 4th (3rd-5th) week of treatment

Other Outcomes (9)

• Major adverse cardiac events (MACE)

  Up to the 12th (11th-13th) week of treatment

• Major bleeding

  Up to the 12th (11th-13th) week of treatment

• Minor bleeding

  Up to the 12th (11th-13th) week of treatment

Study Arms (2)

Berberine Arm

EXPERIMENTAL

In the Berberine Arm, patients will receive 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±1 weeks (Stage 3) in addition to standard treatment, including aspirin 100 mg once daily and clopidogrel 75 mg once daily for 12±1 weeks.

Drug: Berberine; Drug: Standard treatment; Drug: Aspirin; Drug: Clopidogrel

Control Arm

ACTIVE COMPARATOR

In the Control Arm, patients will receive standard treatment, including aspirin 100 mg once daily and clopidogrel 75 mg once daily for 12±1 weeks.

Drug: Standard treatment; Drug: Aspirin; Drug: Clopidogrel

Interventions

Berberine DRUG

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).

Also known as: Berberine Hydrochloride Tablets

Berberine Arm

Standard treatment DRUG

Standard treatment for 12±1 weeks.

Berberine Arm; Control Arm

Aspirin DRUG

Aspirin 100 mg once daily for 12±1 weeks.

Also known as: Aspirin Enteric-coated Tablets, Bayaspirin

Berberine Arm; Control Arm

Clopidogrel DRUG

Clopidogrel 75 mg once daily for 12±1 weeks.

Also known as: Clopidogrel Hydrogen Sulphate Tablets, Plavix

Berberine Arm; Control Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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
• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

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MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Berberine; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 2-Ring

Study Officials

• Zhenyu Liu, M.D.

  Department of Cardiology, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenyu Liu, M.D.

CONTACT

+861069155068; pumch_lzy@163.com

Lihong Xu, B.N.

CONTACT

+861069155068; xulihong1990@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: On the first day of the treatment period (Visit 1), eligible patients will be randomized into the Berberine Arm and the Control Arm. In the Berberine Arm, patients will receive 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±1 weeks (Stage 3) in addition to standard treatment, including aspirin 100 mg once daily and clopidogrel 75 mg once daily for 12±1 weeks. In the Control Arm, patients will receive standard treatment, including aspirin 100 mg once daily and clopidogrel 75 mg once daily for 12±1 weeks.

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 20, 2017
• Study Start: September 26, 2018
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)