Short-Term Outcomes of Early Administration of Colchicine in Non-ST Segment Elevation Myocardial Infarction Patients Treated With Drug-Eluting Stents.

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

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

Qualifiers

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

Treatments tested in this trial

  • Colchicine
  • Placebo

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators