Percutaneous Coronary Intervention Clinical Trial
Official title:
The Study of Berberine Affecting Metabolism, Inflammation Status, Endothelial Function and Thrombotic Events in Patients With Coronary Artery Disease by Remodeling Gut Microbiota
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
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.
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