NCT07143136

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for early_phase_1

Timeline
4mo left

Started Aug 2025

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Aug 2025Sep 2026

Study Start

First participant enrolled

August 10, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 11, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

August 11, 2025

Last Update Submit

August 19, 2025

Conditions

Non ST-Segment Elevation Myocardial Infarction

Keywords

ColchicineInflammationNon-STEMI

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (2)

  • 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

Study Arms (2)

Colchicine group

ACTIVE COMPARATOR
Drug: Colchicine

Control group

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ColchicineDRUG

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

Colchicine group
PlaceboDRUG

Matching Placebo Regimen

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospitals

Asyut, Asyut Governorate, Egypt

RECRUITING

Related Publications (7)

  • Condello F, Sturla M, Reimers B, Liccardo G, Stefanini GG, Condorelli G, Ferrante G. Association Between Colchicine Treatment and Clinical Outcomes in Patients with Coronary Artery Disease: Systematic Review and Meta-analysis. Eur Cardiol. 2021 Oct 21;16:e39. doi: 10.15420/ecr.2021.31. eCollection 2021 Feb.

    PMID: 34777579BACKGROUND

  • Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; ESC Scientific Document Group. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019 Jan 14;40(3):237-269. doi: 10.1093/eurheartj/ehy462. No abstract available.

    PMID: 30165617BACKGROUND

  • Mewton N, Roubille F, Bresson D, Prieur C, Bouleti C, Bochaton T, Ivanes F, Dubreuil O, Biere L, Hayek A, Derimay F, Akodad M, Alos B, Haider L, El Jonhy N, Daw R, De Bourguignon C, Dhelens C, Finet G, Bonnefoy-Cudraz E, Bidaux G, Boutitie F, Maucort-Boulch D, Croisille P, Rioufol G, Prunier F, Angoulvant D. Effect of Colchicine on Myocardial Injury in Acute Myocardial Infarction. Circulation. 2021 Sep 14;144(11):859-869. doi: 10.1161/CIRCULATIONAHA.121.056177. Epub 2021 Aug 23.

    PMID: 34420373BACKGROUND

  • Nidorf SM, Fiolet ATL, Mosterd A, Eikelboom JW, Schut A, Opstal TSJ, The SHK, Xu XF, Ireland MA, Lenderink T, Latchem D, Hoogslag P, Jerzewski A, Nierop P, Whelan A, Hendriks R, Swart H, Schaap J, Kuijper AFM, van Hessen MWJ, Saklani P, Tan I, Thompson AG, Morton A, Judkins C, Bax WA, Dirksen M, Alings M, Hankey GJ, Budgeon CA, Tijssen JGP, Cornel JH, Thompson PL; LoDoCo2 Trial Investigators. Colchicine in Patients with Chronic Coronary Disease. N Engl J Med. 2020 Nov 5;383(19):1838-1847. doi: 10.1056/NEJMoa2021372. Epub 2020 Aug 31.

    PMID: 32865380BACKGROUND

  • Tardif JC, Kouz S, Waters DD, Bertrand OF, Diaz R, Maggioni AP, Pinto FJ, Ibrahim R, Gamra H, Kiwan GS, Berry C, Lopez-Sendon J, Ostadal P, Koenig W, Angoulvant D, Gregoire JC, Lavoie MA, Dube MP, Rhainds D, Provencher M, Blondeau L, Orfanos A, L'Allier PL, Guertin MC, Roubille F. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction. N Engl J Med. 2019 Dec 26;381(26):2497-2505. doi: 10.1056/NEJMoa1912388. Epub 2019 Nov 16.

    PMID: 31733140BACKGROUND

  • Martinez GJ, Celermajer DS, Patel S. The NLRP3 inflammasome and the emerging role of colchicine to inhibit atherosclerosis-associated inflammation. Atherosclerosis. 2018 Feb;269:262-271. doi: 10.1016/j.atherosclerosis.2017.12.027. Epub 2017 Dec 25.

    PMID: 29352570BACKGROUND

  • Libby P. Inflammation in atherosclerosis. Arterioscler Thromb Vasc Biol. 2012 Sep;32(9):2045-51. doi: 10.1161/ATVBAHA.108.179705.

    PMID: 22895665BACKGROUND

MeSH Terms

Conditions

InflammationNon-ST Elevated Myocardial Infarction

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaNecrosis

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Central Study Contacts

Resident Doctor

CONTACT

+201272615212david.17289616@med.aun.edu.eg

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 27, 2025

Study Start

August 10, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

August 27, 2025

Record last verified: 2025-08

Locations

EG(1)