Status:
UNKNOWN
Effect of Berberine for Endothelial Function and Intestinal Microflora in Patients With Coronary Artery Disease
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Stable Coronary Artery Disease
Percutaneous Coronary Intervention
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 mi...
Detailed Description
In the present study, about 48 patients with stable coronary artery disease who are at \> 8 but ≤ 40 weeks after elective percutaneous coronary intervention. The total study duration is expected to be...
Eligibility Criteria
Inclusion
- Patients with stable coronary artery disease undergo elective PCI \>8 weeks, but ≤40 weeks
Exclusion
- Planned coronary revascularization, including PCI and coronary artery bypass graft (CABG) during the study period.
- Subjects with uncontrolled high blood pressure
- Recent (within 4 weeks) dose adjustment of any standard therapy agents
- Recent (within 4 weeks) use of berberine
- History of intolerance to berberine.
- Cr\>1.5mg/dL; ALT level exceeds the upper limit of 3 times
- Heart failure or LVEF \<50%
- Uncontrolled arrhythmia
- Pregnancy or lactation
- Malignant tumor or life expectancy is less than half a year
- Subjects who can not complete the follow-up
Key Trial Info
Start Date :
June 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04434365
Start Date
June 21 2019
End Date
December 30 2020
Last Update
June 16 2020
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730