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

Assiut University

Status and phase: Enrolling; Early Phase 1

Conditions: Non ST-Segment Elevation Myocardial Infarction

Treatments: Drug: Colchicine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07143136

ColchicineInNSTEMI2025

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups, including a placebo group

Colchicine group

Active Comparator group

Treatment:

Drug: Colchicine

Control group

Placebo Comparator group

Treatment:

Drug: Placebo