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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with Non-STEMI

Undergoing PCI with drug-eluting stents

Disqualifiers

Severe renal or hepatic dysfunction

Colchicine hypersensitivity

Active infection and active diarrhea.

Gastrointestinal intolerance

Trial design

Design model

Parallel

Treatments tested in this trial

  • Colchicine

    Drug

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

  • Placebo

    Drug

    Matching Placebo Regimen

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Colchicine groupActive comparator 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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