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

• Status: Active, not recruiting
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Aspirin; Atorvastatin; Clopidogrel; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

Patients with stable coronary artery disease undergo elective PCI >8 weeks, but ≤40 weeks

Exclusion Criteria:

1. Planned coronary revascularization, including PCI and coronary artery bypass graft (CABG) during the study period.

2. Subjects with uncontrolled high blood pressure

3. Recent (within 4 weeks) dose adjustment of any standard therapy agents

4. Recent (within 4 weeks) use of berberine

5. History of intolerance to berberine.

6. Cr>1.5mg/dL; ALT level exceeds the upper limit of 3 times

7. Heart failure or LVEF <50%

8. Uncontrolled arrhythmia

9. Pregnancy or lactation

10. Malignant tumor or life expectancy is less than half a year

11. Subjects who can not complete the follow-up