Efficacy and Safety of Colchicine After PCI
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 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 criteria
This trial does not accept healthy volunteersQualifiers
(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;
Disqualifiers
(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;
Trial design
Design model
Parallel
Treatments tested in this trial
Colchicine 0.5 mg
DrugColchicine 0.5 mg, one pill a day, oral intake
Colchicine 0.375 mg
DrugColchicine 0.375 mg, one pill a day, oral intake
Placebo
DrugPlacebo, one pill a day, oral intake
Treatment groups
8,862 Participants
are divided into 3 treatment groupsGroup A: Colchicine 0.5 mgExperimental treatment 1 intervention
Group B: Colchicine 0.375 mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization
From randomization to the first occurrence
Time frame
An estimated 2-4 years periodSecondary outcomes
1
Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke
From randomization to the first occurrence
Time frame
An estimated 2-4 years period2
Ischemia-driven revascularization
The number of participants with Ischemia-driven revascularization
Time frame
An estimated 2-4 years period3
Nonfatal myocardial infarction
The number of participants with myocardial infarction
Time frame
An estimated 2-4 years period4
Nonfatal stroke
The number of participants with stroke
Time frame
An estimated 2-4 years periodSponsors and contacts
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Source ClinicalTrials.gov