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Effect of Colchicine in Patients With Myocardial Infarction

Megadott ok: Due to the pandemic, there were logistical issues in continuing the study.

Key facts

Where
Rawalpindi, PakisztánSee the site
Phase
2. fázis

Where in Pakisztán

  • Rawalpindi Institute of CardiologyRawalpindi, PakisztánNo longer taking part

Trial details

Who runs it
Shifa Tameer-e-Millat University
Trial code
NCT04218786
Record updated
2023. április 12.
Original description
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.Read full original descriptionShow less

Outcomes of Low-dose Colchicine in Patients With Myocardial Infarction: A Randomized Controlled Trial

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.

Inclusion: All patients 18 years or above presenting in emergency department with acute myocardial infarction. These patients will be requested to take the medication at the time of discharge after stabilization and management.

Exclusion: Patients with prior myocardial infarction 30 days before; Active inflammatory or infectious disease or known malignancy; Known hypersensitivity to colchicine,; hepatic failure; Stent thrombosis; Cardiac arrest or cardiogenic shock as presenting symptoms; renal failure (eGFR <30ml.min.1.73m); Age <18 or > 80 years; Patients with ischemic cardiomyopathy.

ClinicalTrials.gov NCT04218786