Effect of Berberine for Endothelial Function and Intestinal Microflora in Patients With Coronary Artery Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
Summary
- Conditions
- Percutaneous Coronary Intervention
- Stable Coronary Artery Disease
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: On the first day of the treatment period (Visit 1), eligible patients will be randomized into the Berberine Arm and the Control Arm. In the Berberine Arm, patients will receive berberine 200 mg twice daily for 4±1 weeks (Stage 1); then, 300 mg twice daily for 4±1 weeks (Stage 2); then, 400 mg twice daily for 4±1 weeks (Stage 3) in addition to standard treatment, including aspirin 100 mg once daily and clopidogrel 75 mg once daily for 12±1 weeks. In the Control Arm, patients will receive standard treatment, including aspirin 100 mg once daily and clopidogrel 75 mg once daily for 12±1 weeks.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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, Rand...
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: . Endothelial function, as measured by Flow mediated dilation (FMD) from baseline to 12-week follow-up; . 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.
Tracking Information
- NCT #
- NCT04434365
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ran Tian, M.D. Peking Union Medical College Hospital
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