Status:
COMPLETED
Different Doses of Colchicine on hsCRP
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Coronary Artery Disease
Percutaneous Coronary Intervention
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Colchicine reduced atherothrombotic cardiovascular events in the COLCOT and LoDoCo2 studies. US Food and Drug Administration approved colchicine as the first anti-inflammatory drug for cardiovascular ...
Eligibility Criteria
Inclusion
- Volunteer to participate, understand and sign an informed consent form;
- Age ≥ 18 years old, regardless of gender;
- Patient diagnosed with coronary heart disease requiring percutaneous coronary intervention;
- Complete all planned percutaneous coronary intervention during hospitalization;
- Patient must be treated according to national guidelines for standard treatment of coronary heart disease.
Exclusion
- Known allergies to colchicine;
- Colchicine was taken within 10 days before randomization;
- Abnormal liver function test (alanine aminotransferase \>3 times the upper limit of normal value);
- Abnormal renal function test (eGFR\<30mL/min);
- Thrombocytopenia (platelet count \<100 g/L);
- Uncontrolled infectious diseases;
- Known immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, and malignant tumor, etc;
- Pre-existing or plan for the administration of nonsteroidal anti-inflammatory drugs, hormones, immunomodulatory drugs, or chemotherapeutic drugs;
- Pregnant women, lactating women or women of childbearing age who do not use effective contraceptives;
- Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.
Key Trial Info
Start Date :
October 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06078904
Start Date
October 10 2023
End Date
April 15 2024
Last Update
April 16 2024
Active Locations (1)
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1
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022