Efficacy and Safety of Colchicine After PCI

Launched by WUHAN UNION HOSPITAL, CHINA · Jun 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of colchicine, a medication that helps reduce inflammation, on heart health in Chinese patients who have undergone a procedure called Percutaneous Coronary Intervention (PCI) for coronary heart disease (CHD). The main goal is to find out if different doses of colchicine can lower the risk of heart-related issues after PCI and to ensure it is safe for patients in this population. Currently, colchicine is not approved for treating CHD in China, and this study aims to gather important information on its use.

To be eligible for this trial, participants must be between 18 and 80 years old, able to provide consent, and hospitalized for CHD needing PCI. They should have completed all planned procedures during their stay in the hospital. However, individuals with certain conditions, such as allergies to colchicine or severe liver or kidney issues, cannot participate. Those who join can expect regular check-ups and monitoring to assess the medication's effectiveness and safety over time. This research will help determine if colchicine can be a suitable treatment for Chinese patients with CHD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (1) Capable and willing to provide informed consent;
• • (2) Age ≥18 and ≤80 years old, regardless of sex;
• • (3) Hospitalized patients with CHD requiring PCI;
• • (4) Completion of all planned PCI during hospitalization;
• • (5) Standardized treatment of coronary artery disease according to national guidelines.
• Exclusion Criteria:
• • (1) Known allergy to colchicine;
• • (2) Colchicine taken within 10 days prior to randomization group;
• • (3) Patients currently in cardiogenic shock or hemodynamically unstable;
• • (4) Patients with known inflammatory bowel disease or chronic diarrhea;
• • (5) Abnormal liver function (ALT\> 3 times the upper limit of normal);
• • (6) Abnormal renal function (eGFR\<30mL/min/1.73m2);
• • (7) Active malignant tumors reported in past medical history;
• • (8) Existing or planned treatment with other anti-inflammatory or immunosuppressive drugs;
• • (9) Pregnant women, lactating women or women of childbearing age who did 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.