NCT06472908

Efficacy and Safety of Colchicine After PCI

Efficacy and Safety of Colchicine After Percutaneous Coronary Intervention

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,862 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Heart Disease
• Percutaneous Coronary Intervention
• Colchicine

Interventions

Type	Name	Description
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	Placebo	Placebo, one pill a day, oral intake

Timeline

• Start date: 2024-07-09
• Primary completion: 2028-03-31
• Completion: 2028-08-31
• First posted: 2024-06-25
• Last updated: 2025-03-30

Locations

36 sites across 1 country: China