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Effect of Berberine for Endothelial Function and Intestinal Microflora in Patients With Coronary Artery Disease

NCT04434365 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-06-16

No results posted yet for this study

Summary

The purpose of this study is to conduct a single-center, randomized, open-label, controlled, dose-escalating, parallel-group study, evaluating the effects and change of endothelial function and gut microbiota after berberine administration in patients with stable coronary artery disease who are at \> 8 but ≤ 40 weeks after elective percutaneous coronary intervention

Conditions

  • Stable Coronary Artery Disease
  • Percutaneous Coronary Intervention

Interventions

DRUG

Berberine

Berberine 100 mg twice daily for 4±1 weeks (Stage 1); then, 200 mg twice daily for 4±1 weeks (Stage 2); then, 300 mg twice daily for 4 weeks (Stage 3).

DRUG

Aspirin

Aspirin 100 mg once daily for 12±1 weeks.

DRUG

Clopidogrel

Clopidogrel 75 mg once daily for 12±1 weeks.

DRUG

Statin

Statins once daily for 12±1 weeks.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Ran Tian, M.D. · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-21
Primary Completion
2019-11-18
Completion
2020-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04434365 on ClinicalTrials.gov