Different Doses of Colchicine on hsCRP

NCT06078904 | Completed Phase 4 DMC

• 1 other identifier: COLCRP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• The percentage change in hsCRP

  The percentage change in hsCRP compared to baseline

  4 weeks

Secondary Outcomes (5)

• Major adverse cardiac and cerebrovascular event (MACCE)

  4 weeks

• Bleeding

  4 weeks

• Plasma inflammatory cytokines level

  4 weeks

• Blood drug concentrations of different doses of colchicine

  4 weeks

• Expression of inflammation-related proteins in peripheral blood mononuclear cells

  4 weeks

Study Arms (4)

Colchicine 0.5 MG

ACTIVE COMPARATOR

Colchicine 0.5 MG, one pill a day, oral intake

Drug: Colchicine 0.5 MG

Colchicine 0.375 MG

ACTIVE COMPARATOR

Colchicine 0.375 MG, one pill a day, oral intake

Drug: Colchicine 0.375 MG

Colchicine 0.25 MG

ACTIVE COMPARATOR

Colchicine 0.25 MG, one pill a day, oral intake

Drug: Colchicine 0.25 MG

Placebo

PLACEBO COMPARATOR

Placebo, one pill a day, oral intake

Drug: Placebo

Interventions

Colchicine 0.5 MG DRUG

Colchicine 0.5 MG, one pill a day, oral intake

Colchicine 0.5 MG

Colchicine 0.375 MG DRUG

Colchicine 0.375 MG, one pill a day, oral intake

Colchicine 0.375 MG

Colchicine 0.25 MG DRUG

Colchicine 0.25 MG, one pill a day, oral intake

Colchicine 0.25 MG

Placebo DRUG

Placebo, one pill a day, oral intake

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Related 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.

  PMID: 33769515 BACKGROUND

• 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.

  PMID: 37558377 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director in the department of cardiology

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 12, 2023
• Study Start: October 10, 2023
• Primary Completion: December 25, 2023
• Study Completion: April 15, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)