Different Doses of Colchicine on hsCRP

Sponsor

Wuhan Union Hospital, China (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06078904

Collaborator

(none)

200

Enrollment

Location

Arms

3.2

Anticipated Duration (Months)

62.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Percutaneous Coronary Intervention	Drug: Colchicine 0.5 MG Drug: Colchicine 0.375 MG Drug: Colchicine 0.25 MG Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 10, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jan 15, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

The percentage change in hsCRP [4 weeks]
The percentage change in hsCRP compared to baseline

Secondary Outcome Measures

Major adverse cardiac and cerebrovascular event (MACCE) [4 weeks]
Composite endpoint of all cause death, non fatal myocardial infarction, non fatal stroke, and revascularization due to ischemia
Bleeding [4 weeks]
Bleeding defined according to Bleeding Academic Research Consortium
Plasma inflammatory cytokines level [4 weeks]
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 [4 weeks]
Blood drug concentrations of different doses of colchicine
Expression of inflammation-related proteins in peripheral blood mononuclear cells [4 weeks]
Inflammation-related proteins (nucleotide-binding oligomerization domain-like receptor protein 3, absent in melanoma 2, etc)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430022

Sponsors and Collaborators

Wuhan Union Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Xiang Cheng, Director in the department of cardiology, Wuhan Union Hospital, China

ClinicalTrials.gov Identifier:

NCT06078904

Other Study ID Numbers:

COLCRP

First Posted:

Oct 12, 2023

Last Update Posted:

Oct 12, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Coronary Artery Disease

Colchicine

Study Results

No Results Posted as of Oct 12, 2023