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Effect of Colchicine in Patients With Myocardial Infarction

NCT04218786 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-04-12

No results posted yet for this study

Summary

Over the past years, a substantial volume of evidence has accumulated identifying inflammatory processes as key mediators of the deleterious effects of ischemia/reperfusion-related phenomena in patients presenting with ST-segment-elevation myocardial infarction (STEMI). Nevertheless, equally impressive is the lack of clinically applicable therapeutic strategies that could mitigate these processes, thus providing significant cardioprotection. Despite the well-known fact that inflammation plays an important role in coronary artery disease development and progression, there have been few attempts to systematically examine the potential role of anti-inflammatory treatment in this setting, possibly because of a lack in anti-inflammatory agents without the adverse cardiovascular safety profile of corticosteroids and nonsteroidal anti-inflammatory drugs. Colchicine is a substance with potent anti-inflammatory properties, having a unique mechanism of action, which allows for safe use in patients with cardiovascular disease.

The purpose of the present clinical study is to test the hypothesis that a short course of treatment with colchicine could lead to reduced major adverse cardiovascular events (MACE) in acute MI.

Conditions

Interventions

DRUG

Colchicine

The tablet will be given once daily for the span of the study

DRUG

Placebo oral tablet

The tablet will be given once daily for the span of the study

Sponsors & Collaborators

  • Rawalpindi Institute of Cardiology

    collaborator OTHER

  • Shifa Tameer-e-Millat University

    lead OTHER

Principal Investigators

  • Nismat Javed, MBBS (2021) · Shifa College of Medicine, Shifa Tameer-e-Millat University

  • Jahanzeb Malik, MBBS (2011) · Rawalpindi Institute of Cardiology

  • Adeel ur Rehman, MBBS, FCPS · Rawalpindi Institute of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-03-31
Completion
2026-06-30

Countries

  • Pakistan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04218786 on ClinicalTrials.gov