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Efficacy and Safety of Colchicine After PCI

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Primary completion moved earlier from Mar 31, 2028 to Jun 30, 2027 · Completion moved earlier from Aug 31, 2028 to Aug 31, 2027 · Site details revised at 36 of 36 sitesv3 Show 3 more changesShow less
    • Primary completion moved earlier from Mar 31, 2028 to Jun 30, 2027
    • Completion moved earlier from Aug 31, 2028 to Aug 31, 2027
    • Site details revised at 36 of 36 sites
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 42 to 36 · Start date changed from estimate of Jul 6, 2024 to Jul 9, 2024v2 Show 2 more changesShow less
    • Study sites: 42 to 36
    • Start date changed from estimate of Jul 6, 2024 to Jul 9, 2024
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06472908
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions Coronary Heart Disease, Percutaneous Coronary Intervention, Colchicine
Enrollment 8,862 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov