Different Doses of Colchicine on hsCRP

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention
• Intervention / Treatment: Drug: Colchicine 0.5 MG; Drug: Colchicine 0.375 MG; Drug: Colchicine 0.25 MG; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Colchicine 0.5 MG; Colchicine 0.5 MG, one pill a day, oral intake	Drug: Colchicine 0.5 MG; Colchicine 0.5 MG, one pill a day, oral intake
Active Comparator: Colchicine 0.375 MG; Colchicine 0.375 MG, one pill a day, oral intake	Drug: Colchicine 0.375 MG; Colchicine 0.375 MG, one pill a day, oral intake
Active Comparator: Colchicine 0.25 MG; Colchicine 0.25 MG, one pill a day, oral intake	Drug: Colchicine 0.25 MG; Colchicine 0.25 MG, one pill a day, oral intake
Placebo Comparator: Placebo; Placebo, one pill a day, oral intake	Drug: Placebo; Placebo, one pill a day, oral intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage change in hsCRP	The percentage change in hsCRP compared to baseline	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Bleeding	Bleeding defined according to Bleeding Academic Research Consortium	4 weeks
Plasma inflammatory cytokines level	Inflammatory cytokines (IL-1β, IL-1receptor antagonist, IL-6, IL-18, tumor necrosis factor-α, myeloperoxidase, etc)	4 weeks
Blood drug concentrations of different doses of colchicine	Blood drug concentrations of different doses of colchicine	4 weeks
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

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Publications and helpful links

General Publications

• 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;:
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Actual): December 25, 2023
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: COLCRP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No