Early colchicine before drug-eluting stent placement for non‑STEMI patients
Short-Term Outcomes of Early Administration of Colchicine in Non-ST Segment Elevation Myocardial Infarction Patients Treated With Drug-Eluting Stents.
This trial will test whether a short course of colchicine given before and after PCI helps people with non‑ST elevation heart attacks treated with drug‑eluting stents.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut, Asyut Governorate) |
| Trial ID | NCT07143136 on ClinicalTrials.gov |
What this trial studies
Inflammation plays a central role in atherosclerosis and may affect outcomes after PCI, and colchicine is an anti‑inflammatory drug with supportive data in chronic coronary disease. This early-phase interventional trial gives a colchicine loading dose before PCI and continues short-term colchicine versus placebo in patients with non‑STEMI receiving drug‑eluting stents. Short-term clinical endpoints and inflammation-related biomarkers will be compared between the colchicine and placebo groups to gauge peri-procedural effects. The trial is conducted at Assiut University Hospitals and focuses on immediate post-PCI outcomes rather than long-term event reduction.
Who should consider this trial
Good fit: Ideal candidates are adults with non‑ST elevation myocardial infarction who are planned for PCI with drug‑eluting stents and who do not have severe renal or hepatic dysfunction, colchicine hypersensitivity, active infection or diarrhea, pregnancy, breastfeeding, or cardiogenic shock.
Not a fit: Patients with STEMI, cardiogenic shock, severe organ dysfunction, pregnancy or breastfeeding, active infection, or known colchicine intolerance are excluded and unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, peri-procedural colchicine could reduce inflammation and short-term complications after PCI, potentially lowering early ischemic events or stent-related problems.
How similar studies have performed: Large trials such as COLCOT and LoDoCo2 showed benefit of colchicine in chronic coronary disease, but recent acute‑MI trials (OASIS 9, COVERT‑MI) did not support short-term colchicine in STEMI, and peri-procedural use in non‑STEMI is not well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Asyut, Asyut Governorate
- Assiut University Hospitals — Asyut, Asyut Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Resident Doctor
- Email: david.17289616@med.aun.edu.eg
- Phone: +201272615212
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.