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

NCT03378934 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-11-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Zhenyu Liu, M.D. · Department of Cardiology, Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2026-06-30
Completion
2026-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03378934 on ClinicalTrials.gov