Efficacy and Safety of Colchicine After PCI

Condition(s) studied

Investigational drug(s) / intervention(s)

Colchicine 0.5 mg: Colchicine 0.5 mg, one pill a day, oral intake

Colchicine 0.375 mg: Colchicine 0.375 mg, one pill a day, oral intake

Placebo: Placebo, one pill a day, oral intake

Study 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

Primary outcome measure(s)

• 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

Trial sites (36)

More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China

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