Clinical trial NCT06078904: Different Doses of Colchicine on hsCRP
Official title: The Effects of Different Doses of Colchicine on High-sensitivity C-reactive Protein in Patients After Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The percentage change in hsCRP
timeFrame: 4 weeks
Secondary outcomes:
measure: Major adverse cardiac and cerebrovascular event (MACCE)
timeFrame: 4 weeks
measure: Bleeding
timeFrame: 4 weeks
measure: Plasma inflammatory cytokines level
timeFrame: 4 weeks
measure: Blood drug concentrations of different doses of colchicine
timeFrame: 4 weeks
measure: Expression of inflammation-related proteins in peripheral blood mononuclear cells
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
citation: Fiolet ATL, Opstal TSJ, Mosterd A, Eikelboom JW, Jolly SS, Keech AC, Kelly P, Tong DC, Layland J, Nidorf SM, Thompson PL, Budgeon C, Tijssen JGP, Cornel JH. Efficacy and safety of low-dose colchicine in patients with coronary disease: a systematic review and meta-analysis of randomized trials. Eur Heart J. 2021 Jul 21;42(28):2765-2775. doi: 10.1093/eurheartj/ehab115.
citation: Nelson K, Fuster V, Ridker PM. Low-Dose Colchicine for Secondary Prevention of Coronary Artery Disease: JACC Review Topic of the Week. J Am Coll Cardiol. 2023 Aug 15;82(7):648-660. doi: 10.1016/j.jacc.2023.05.055.