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

Not Applicable

Recruiting

• Conditions: Non ST-Segment Elevation Myocardial Infarction
• Interventions: Drug: Colchicine; Drug: Placebo

• Registration Number: NCT07143136
• Lead Sponsor: Assiut University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-10
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-19
• Last Update Submitted: 2025-08-19
• Study First Posted: 2025-08-27
• Last Update Posted: 2025-08-27
• Primary Completion: 2026-03
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Diagnosed with Non-STEMI
• Undergoing PCI with drug-eluting stents

Exclusion Criteria

• Severe renal or hepatic dysfunction
• Colchicine hypersensitivity
• Active infection and active diarrhea.
• Gastrointestinal intolerance
• Pregnancy or breastfeeding.
• Cardiogenic shock

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colchicine group	Colchicine	-
Control group	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of MACE (composite of cardiovascular death, non-fatal MI, stroke, urgent revascularization) at 30 days and 6 months.	6 months

Secondary Outcome Measures

Name	Time	Method
Rate of gastrointestinal side effects and other colchicine-related adverse events.	3 months
Change in CRP from baseline to 3 months post-PCI	3 months

Trial Locations

Locations (1)

Assiut University Hospitals; 🇪🇬 Asyut, Asyut Governorate, Egypt