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NCT Number: NCT07143136

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Assiut University Hospitals

Asyut, Asyut Governorate, Egypt

Location status: Recruiting

Location contact

Vice president of graduate studies of Assiut University

CONTACT

[email protected]

+2088 22080150

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine

Drug

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

Placebo

Drug

Matching Placebo Regimen

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. Rate of gastrointestinal side effects and other colchicine-related adverse events.

    Time frame: 3 months

  2. Change in CRP from baseline to 3 months post-PCI

    Time frame: 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Resident Doctor

CONTACT

[email protected]

+201272615212

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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