NCT04434365

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

The Study of Berberine Affecting Metabolism, Inflammation Status, Endothelial Function and Thrombotic Events in Patients With Coronary Artery Disease by Remodeling Gut Microbiota

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

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 approximately 14 weeks per patient, including a screening period, a 12±1 week treatment period, Randomization was computer generated. After screening, eligible subjects will be randomly assigned into one of the following two groups: Berberine+therapy Arm or Standard therapy Arm. The primary objective is to determine whether a combination of berberine and coronary artery disease standard therapy is preferable to either berberine alone or standard therapy alone. The visit schedule will be as follows: Visit 1: Day -7 to Day -1, Screening/Enrolment; Visit 2: Day 1, Randomization/First dose; Visit 3: Week 4±1, Dose adjustment 1, BBR (100mg, tid); Visit 4: Week 8±1, Dose adjustment 2, BBR (200mg, tid); Visit 5: Week 12±1, End of Treatment (EOT) /Last dose, BBR (300mg, tid); Safety visit. We perform cross-sectional comparisons between the two arms and longitudinal comparisons within each arm to evaluate the indicators as follows: 1. . Endothelial function, as measured by Flow mediated dilation (FMD) from baseline to 12-week follow-up; 2. . Gut microbiota, as sequenced by metagenomic sequencing from baseline to 12-week follow-up. Blood and feces samples will be collected before and after treatment. Flow mediated dilation (FMD), HbA1C, fasting plasma glucose (FPG), lipids and cholesterol level, inflammatory factors, amino acids, bile acids and other metabolic related components and parameters will be measured. Furthermore, the change of gut microbiota will be evaluated too.

Conditions

• Stable Coronary Artery Disease
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-21
• Primary completion: 2019-11-18
• Completion: 2020-12-30
• First posted: 2020-06-16
• Last updated: 2020-06-16

Locations

1 site across 1 country: China