Different Doses of Colchicine on hsCRP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2024-04-15

Brief Summary

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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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Detailed Description

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Conditions

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Coronary Artery Disease Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Colchicine 0.5 MG

Colchicine 0.5 MG, one pill a day, oral intake

Group Type ACTIVE_COMPARATOR

Colchicine 0.5 MG

Intervention Type DRUG

Colchicine 0.5 MG, one pill a day, oral intake

Colchicine 0.375 MG

Colchicine 0.375 MG, one pill a day, oral intake

Group Type ACTIVE_COMPARATOR

Colchicine 0.375 MG

Intervention Type DRUG

Colchicine 0.375 MG, one pill a day, oral intake

Colchicine 0.25 MG

Colchicine 0.25 MG, one pill a day, oral intake

Group Type ACTIVE_COMPARATOR

Colchicine 0.25 MG

Intervention Type DRUG

Colchicine 0.25 MG, one pill a day, oral intake

Placebo

Placebo, one pill a day, oral intake

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, one pill a day, oral intake

Interventions

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Colchicine 0.5 MG

Colchicine 0.5 MG, one pill a day, oral intake

Intervention Type DRUG

Colchicine 0.375 MG

Colchicine 0.375 MG, one pill a day, oral intake

Intervention Type DRUG

Colchicine 0.25 MG

Colchicine 0.25 MG, one pill a day, oral intake

Intervention Type DRUG

Placebo

Placebo, one pill a day, oral intake

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No