NCT06472908 Efficacy and Safety of Colchicine After PCI
| NCT ID | NCT06472908 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Coronary Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 8,862 participants |
| Start Date | 2024-07-09 |
| Primary Completion | 2028-03-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Colchicine (0.5 mg/day) was recommended by the U.S. Food and Drug Administration in 2023 for the anti-inflammatory treatment of coronary heart disease (CHD). However, colchicine is still not approved for CHD treatment in China. There is no large-scale clinical evidence that colchicine can be used to treat Chinese patients with CHD. Considering the low body weight of the East Asian population, it is unclear whether the recommended standard dose (0.5 mg/day) is suitable for Chinese patients. Therefore, we need to further explore the effects of different doses of colchicine on the efficacy and safety of clinical endpoints in the Chinese population with CHD. This study is a multicenter, prospective, randomized, controlled, double-blind, event-driven clinical study conducted in China. The primary objective of this study is to determine whether long-term treatment with different doses of colchicine reduces the incidence of cardiovascular events in Chinese patients undergoing PCI. The secondary objective is to determine the safety of long-term treatment with different doses of colchicine in this patient population.
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