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Different Doses of Colchicine on hsCRP

NCT06078904 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-04-16

No results posted yet for this study

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

Interventions

DRUG

Colchicine 0.5 MG

Colchicine 0.5 MG, one pill a day, oral intake

DRUG

Colchicine 0.375 MG

Colchicine 0.375 MG, one pill a day, oral intake

DRUG

Colchicine 0.25 MG

Colchicine 0.25 MG, one pill a day, oral intake

DRUG

Placebo

Placebo, one pill a day, oral intake

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2023-12-25
Completion
2024-04-15

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06078904 on ClinicalTrials.gov