Different Doses of Colchicine on hsCRP

Coronary Artery Disease Clinical Trial

Official title:

The Effects of Different Doses of Colchicine on High-sensitivity C-reactive Protein in Patients After Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06078904
• Other study ID #: COLCRP
• Status: Completed
• Phase: Phase 4
• Start date: October 10, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 15, 2024
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Percutaneous Coronary Intervention

Intervention

Drug:
• Colchicine 0.5 MG
Colchicine 0.5 MG, one pill a day, oral intake
• Colchicine 0.375 MG
Colchicine 0.375 MG, one pill a day, oral intake
• Colchicine 0.25 MG
Colchicine 0.25 MG, one pill a day, oral intake
• Placebo
Placebo, one pill a day, oral intake

Locations

Country	Name	City	State
China	Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Erratum In: Eur Heart J. 2021 May 23;: — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage change in hsCRP	The percentage change in hsCRP compared to baseline	4 weeks
Secondary	Major adverse cardiac and cerebrovascular event (MACCE)	Composite endpoint of all cause death, non fatal myocardial infarction, non fatal stroke, and revascularization due to ischemia	4 weeks
Secondary	Bleeding	Bleeding defined according to Bleeding Academic Research Consortium	4 weeks
Secondary	Plasma inflammatory cytokines level	Inflammatory cytokines (IL-1ß, IL-1receptor antagonist, IL-6, IL-18, tumor necrosis factor-a, myeloperoxidase, etc)	4 weeks
Secondary	Blood drug concentrations of different doses of colchicine	Blood drug concentrations of different doses of colchicine	4 weeks
Secondary	Expression of inflammation-related proteins in peripheral blood mononuclear cells	Inflammation-related proteins (nucleotide-binding oligomerization domain-like receptor protein 3, absent in melanoma 2, etc)	4 weeks