Different Doses of Colchicine on hsCRP

Huazhong University of Science and Technology

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention

Treatments: Drug: Colchicine 0.5 MG; Drug: Colchicine 0.375 MG; Drug: Colchicine 0.25 MG; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06078904

COLCRP

Details and patient eligibility

About

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 diseases on June, 2023. However, there is a lack of evidence for colchicine in East Asian population with coronary heart disease, and its effectiveness and safety need further exploration. Therefore, this study aims to use different doses of colchicine to treat patients with coronary heart disease after percutaneous coronary intervention, explore the effects of different doses of colchicine on hsCRP levels, and find the optimal dose of colchicine for treating coronary heart disease in China.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Volunteer to participate, understand and sign an informed consent form;
2. Age ≥ 18 years old, regardless of gender;
3. Patient diagnosed with coronary heart disease requiring percutaneous coronary intervention;
4. Complete all planned percutaneous coronary intervention during hospitalization;
5. Patient must be treated according to national guidelines for standard treatment of coronary heart disease.

Exclusion criteria

1. Known allergies to colchicine;
2. Colchicine was taken within 10 days before randomization;
3. Abnormal liver function test (alanine aminotransferase >3 times the upper limit of normal value);
4. Abnormal renal function test (eGFR<30mL/min);
5. Thrombocytopenia (platelet count <100 g/L);
6. Uncontrolled infectious diseases;
7. Known immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, and malignant tumor, etc;
8. Pre-existing or plan for the administration of nonsteroidal anti-inflammatory drugs, hormones, immunomodulatory drugs, or chemotherapeutic drugs;
9. Pregnant women, lactating women or women of childbearing age who do not use effective contraceptives;
10. Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

Colchicine 0.5 MG

Active Comparator group

Description:

Colchicine 0.5 MG, one pill a day, oral intake

Treatment:

Drug: Colchicine 0.5 MG

Colchicine 0.375 MG

Active Comparator group

Description:

Colchicine 0.375 MG, one pill a day, oral intake

Treatment:

Drug: Colchicine 0.375 MG

Colchicine 0.25 MG

Active Comparator group

Description:

Colchicine 0.25 MG, one pill a day, oral intake

Treatment:

Drug: Colchicine 0.25 MG

Placebo

Placebo Comparator group

Description:

Placebo, one pill a day, oral intake

Treatment:

Drug: Placebo