Colchicine, Coronary Heart Disease, Percutaneous Coronary Intervention
Conditions
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.
Detailed description
After informed consent, 8862 subjects who meet all inclusion will be randomly assigned to receive colchicine (0.5 mg/day), colchicine (0.375 mg/day), or placebo (1:1:1 allocation ratio), with follow-up at months (1, 6, 12, 18, 24…) after randomization, and phone assessments at months (3, 9, 15, 21…). The occurrence of any endpoints or other adverse events will be assessed every 3 months. Subjects will also receive standard medical care for antiplatelets, control of dyslipidemia, hypertension, angina and diabetes as directed by national guidelines. All suspected cardiovascular endpoints will be adjudicated by the Clinical Event Committee (CEC, consisting of three experienced members blinded as to allocation of therapy). The Data and Safety Monitoring Board (DSMB, consisting of five fully independent members) will review unblinded safety data as detailed in the DSMB charter. An interim analysis is planned after approximately 50% of primary endpoints have been positively adjudicated. The DSMB charter will pre-specify the methodology for the interim analysis and the rules for early termination of the study.
Interventions
DRUGColchicine 0.5 mg
Colchicine 0.5 mg, one pill a day, oral intake
Colchicine 0.375 mg, one pill a day, oral intake
DRUGPlacebo
Placebo, one pill a day, oral intake
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization | An estimated 2-4 years period | From randomization to the first occurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke | An estimated 2-4 years period | From randomization to the first occurrence |
| Ischemia-driven revascularization | An estimated 2-4 years period | The number of participants with Ischemia-driven revascularization |
| Nonfatal myocardial infarction | An estimated 2-4 years period | The number of participants with myocardial infarction |
| Nonfatal stroke | An estimated 2-4 years period | The number of participants with stroke |
| Urgent hospitalization for unstable angina | An estimated 2-4 years period | The number of participants with urgent hospitalization for unstable angina |
| In-stent restenosis | An estimated 2-4 years period | The number of participants with in-stent restenosis |
| Stent thrombosis | An estimated 2-4 years period | The number of participants with stent thrombosis |
| Cardiovascular death | An estimated 2-4 years period | The number of participants with cardiovascular death |
| All-cause mortality | An estimated 2-4 years period | The number of participants with all-cause death |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXiang Cheng, MD
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed