Back to resultsDifferent Doses of Colchicine on hsCRP
Primary Purpose
Coronary Artery Disease, Percutaneous Coronary Intervention
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Colchicine 0.5 MG
Colchicine 0.375 MG
Colchicine 0.25 MG
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
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.
Sites / Locations
- Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Colchicine 0.5 MG
Colchicine 0.375 MG
Colchicine 0.25 MG
Placebo
Arm Description
Colchicine 0.5 MG, one pill a day, oral intake
Colchicine 0.375 MG, one pill a day, oral intake
Colchicine 0.25 MG, one pill a day, oral intake
Placebo, one pill a day, oral intake
Outcomes
Primary Outcome Measures
The percentage change in hsCRP
The percentage change in hsCRP compared to baseline
Secondary Outcome Measures
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
Bleeding
Bleeding defined according to Bleeding Academic Research Consortium
Plasma inflammatory cytokines level
Inflammatory cytokines (IL-1β, IL-1receptor antagonist, IL-6, IL-18, tumor necrosis factor-α, myeloperoxidase, etc)
Blood drug concentrations of different doses of colchicine
Blood drug concentrations of different doses of colchicine
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)
Full Information
NCT ID
NCT06078904
First Posted
October 5, 2023
Last Updated
October 5, 2023
Sponsor
Wuhan Union Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT06078904
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 10, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Percutaneous Coronary Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Colchicine 0.5 MG
Arm Type
Active Comparator
Arm Description
Colchicine 0.5 MG, one pill a day, oral intake
Arm Title
Colchicine 0.375 MG
Arm Type
Active Comparator
Arm Description
Colchicine 0.375 MG, one pill a day, oral intake
Arm Title
Colchicine 0.25 MG
Arm Type
Active Comparator
Arm Description
Colchicine 0.25 MG, one pill a day, oral intake
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, one pill a day, oral intake
Intervention Type
Drug
Intervention Name(s)
Colchicine 0.5 MG
Intervention Description
Colchicine 0.5 MG, one pill a day, oral intake
Intervention Type
Drug
Intervention Name(s)
Colchicine 0.375 MG
Intervention Description
Colchicine 0.375 MG, one pill a day, oral intake
Intervention Type
Drug
Intervention Name(s)
Colchicine 0.25 MG
Intervention Description
Colchicine 0.25 MG, one pill a day, oral intake
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, one pill a day, oral intake
Primary Outcome Measure Information:
Title
The percentage change in hsCRP
Description
The percentage change in hsCRP compared to baseline
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Major adverse cardiac and cerebrovascular event (MACCE)
Description
Composite endpoint of all cause death, non fatal myocardial infarction, non fatal stroke, and revascularization due to ischemia
Time Frame
4 weeks
Title
Bleeding
Description
Bleeding defined according to Bleeding Academic Research Consortium
Time Frame
4 weeks
Title
Plasma inflammatory cytokines level
Description
Inflammatory cytokines (IL-1β, IL-1receptor antagonist, IL-6, IL-18, tumor necrosis factor-α, myeloperoxidase, etc)
Time Frame
4 weeks
Title
Blood drug concentrations of different doses of colchicine
Description
Blood drug concentrations of different doses of colchicine
Time Frame
4 weeks
Title
Expression of inflammation-related proteins in peripheral blood mononuclear cells
Description
Inflammation-related proteins (nucleotide-binding oligomerization domain-like receptor protein 3, absent in melanoma 2, etc)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33769515
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. Erratum In: Eur Heart J. 2021 May 23;:
Results Reference
background
PubMed Identifier
37558377
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.
Results Reference
background
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Different Doses of Colchicine on hsCRP
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