Efficacy and Safety of Colchicine After PCI

Huazhong University of Science and Technology

Status and phase: Enrolling; Phase 3

Conditions: Percutaneous Coronary Intervention; Coronary Heart Disease; Colchicine

Treatments: Drug: Colchicine 0.375 mg; Drug: Placebo; Drug: Colchicine 0.5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06472908

COLPCI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,862 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8,862 participants in 3 patient groups, including a placebo group

Colchicine 0.5 mg

Experimental group

Description:

Colchicine 0.5 mg, one pill a day, oral intake

Treatment:

Drug: Colchicine 0.5 mg

Colchicine 0.375 mg

Experimental group

Description:

Colchicine 0.375 mg, one pill a day, oral intake

Treatment:

Drug: Colchicine 0.375 mg

Placebo

Placebo Comparator group

Description:

Placebo, one pill a day, oral intake

Treatment:

Drug: Placebo