About this trial
Inflammation plays a central role in the pathophysiology of atherosclerosis and in the progression of coronary artery. Colchicine, an anti-inflammatory agent traditionally used for gout and pericarditis, has emerged as a potential therapy in cardiovascular disease due to its ability to inhibit microtubule polymerization and suppress interleukin-1β and the NLRP3 inflammasome pathway.
COLCOT and LoDoCo2 trails have demonstrated the efficacy of colchicine in reducing cardiovascular events in patients with coronary artery disease.
However, more recent trials, including OASIS 9 and COVERT-MI trials did not support the use of a short-term colchicine treatment at the acute phase of ST segment elevation myocardial infarction (STEMI) to reduce infarct size and improve outcomes. Limited data exist on the peri-procedural use of colchicine in non-ST elevation myocardial infarction patients undergoing PCI.
This study proposes to assess whether a loading dose of colchicine before PCI, followed by 3-months maintenance therapy, can improve short-term clinical outcomes and inflammatory markers in non- STEMI patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with Non-STEMI
Undergoing PCI with drug-eluting stents
Disqualifiers
Severe renal or hepatic dysfunction
Colchicine hypersensitivity
Active infection and active diarrhea.
Gastrointestinal intolerance
Trial design
Parallel
Treatments tested in this trial
Colchicine
DrugAdministration of Colchicine 1 day before and 90 days after PCI in Non-STEMI Patients
Placebo
DrugMatching Placebo Regimen
Treatment groups
Trial outcomes
Primary outcomes
Incidence of MACE (composite of cardiovascular death, non-fatal MI, stroke, urgent revascularization) at 30 days and 6 months.
Secondary outcomes
Rate of gastrointestinal side effects and other colchicine-related adverse events.
Change in CRP from baseline to 3 months post-PCI
Sponsors and contacts
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