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Effect of berberine hydrochloride on clinical outcomes in patients with stable coronary artery disease after PCI: a prospective, multicenter, randomized controlled clinical trial

Effect of berberine hydrochloride on clinical outcomes in patients with stable coronary artery disease after PCI: a prospective, multicenter, randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023731
Enrollment
Unknown
Registered
2019-06-09
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Interventions

Experimental group:Berberine hydrochloride+Standard treatment
Control group:Standard treatment

Sponsors

First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged = 18 years old; 2. coronary angiography confirmed at least one coronary artery stenosis >70%; or left main lesion stenosis >50%; 3. Meet the diagnostic criteria for stable coronary heart disease; 4. There must be evidence of objective examination of myocardial ischemia: positive plate test, FFR <0.75, positive myocardial load test, etc.; 5. can not use the drugs prohibited in the program throughout the study; 6. A dose-loaded dual antiplatelet drug (ASA 300mg + clopidogrel 300mg) and any statin therapy have been given before PCI; 7. Subjects are willing to comply with all aspects of the research protocol, including adherence to the assigned treatment strategy, medication and follow-up; 8. To be able to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. combined with severe heart valve disease; 2. Consolidate severe congenital heart disease; 3. combined with hyperthyroidism such as hyperthyroidism and anemia; 4. combined with pulmonary heart disease; 5. combined with hypertrophic obstructive cardiomyopathy; 6. severe hypotension (SBP 160 mm Hg, and / or DBP > 100 mm Hg); 8. Hepatic insufficiency (defined as ALT or total bilirubin greater than 3 times the upper limit of normal); 9. renal insufficiency (defined as blood creatinine greater than 1.5 times the upper limit of normal); 10. Patients at high risk of bleeding, such as thrombocytopenia, blood system diseases, etc.; 11. Active peptic ulcer and skin ulcers; 12. Patients who are allergic to clopidogrel, aspirin, statins, and berberine; 13. Patients with a history of cardiogenic shock within two weeks; 14. Pregnant and lactating women, women of childbearing age who cannot be strictly contravented during treatment; 15. Participated in other clinical researchers in the past 3 months; 16. Those who do not have legal capacity or limited legal capacity; 17.. Any situation that the investigator believes is not suitable for participation in the clinical study.

Design outcomes

Primary

MeasureTime frame
MACE;

Secondary

MeasureTime frame
all-cause death;cardiac death;ST;Nonfatal myocardial infarction;Target vessel reconstruction;Stroke;lipids change;

Countries

China

Contacts

Public ContactXiang Xie

Heart Center, the First Affiliated Hospital of Xinjiang Medical University

xiangxie999@sina.com+86 15099169036

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026