Efficacy and Safety of Colchicine After PCI
Recruiting
Phase 3
Interventional Study
Coronary Heart Disease
Percutaneous Coronary Intervention
Colchicine
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 8,862 (estimated)
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Other
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About This Trial
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 i…
Trial Locations
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Eligibility Criteria
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 acco…
Contacts