NCT07143136

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non ST-Segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Colchicine	Administration of Colchicine 1 day before and 90 days after PCI in Non-STEMI Patients
DRUG	Placebo	Matching Placebo Regimen

Timeline

• Start date: 2025-08-10
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2025-08-27
• Last updated: 2025-08-27

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study