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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07143136
Enrollment
140
Registered
2025-08-27
Start date
2025-08-10
Completion date
2026-09-30
Last updated
2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non ST-Segment Elevation Myocardial Infarction

Keywords

Colchicine, Inflammation, Non-STEMI

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.

Interventions

DRUGColchicine

Administration of Colchicine 1 day before and 90 days after PCI in Non-STEMI Patients

DRUGPlacebo

Matching Placebo Regimen

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Rate of gastrointestinal side effects and other colchicine-related adverse events.3 months
Change in CRP from baseline to 3 months post-PCI3 months

Countries

Egypt

Contacts

Primary ContactResident Doctor
david.17289616@med.aun.edu.eg+201272615212

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026