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OpenTrials
Completed

NCT Number: NCT06078904

Different Doses of Colchicine on hsCRP

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Wuhan, Hubei, 430022, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Colchicine 0.5 MG

Drug

Colchicine 0.5 MG, one pill a day, oral intake

Colchicine 0.375 MG

Drug

Colchicine 0.375 MG, one pill a day, oral intake

Colchicine 0.25 MG

Drug

Colchicine 0.25 MG, one pill a day, oral intake

Placebo

Drug

Placebo, one pill a day, oral intake

Primary outcomes

  1. The percentage change in hsCRP

    Time frame: 4 weeks

    The percentage change in hsCRP compared to baseline

Secondary outcomes

  1. Major adverse cardiac and cerebrovascular event (MACCE)

    Time frame: 4 weeks

    Composite endpoint of all cause death, non fatal myocardial infarction, non fatal stroke, and revascularization due to ischemia

  2. Bleeding

    Time frame: 4 weeks

    Bleeding defined according to Bleeding Academic Research Consortium

  3. Plasma inflammatory cytokines level

    Time frame: 4 weeks

    Inflammatory cytokines (IL-1β, IL-1receptor antagonist, IL-6, IL-18, tumor necrosis factor-α, myeloperoxidase, etc)

  4. Blood drug concentrations of different doses of colchicine

    Time frame: 4 weeks

    Blood drug concentrations of different doses of colchicine

  5. Expression of inflammation-related proteins in peripheral blood mononuclear cells

    Time frame: 4 weeks

    Inflammation-related proteins (nucleotide-binding oligomerization domain-like receptor protein 3, absent in melanoma 2, etc)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 12, 2023
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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