Effect of Colchicine in Patients With Myocardial Infarction

NCT04218786 | Withdrawn Phase 2 DMC

• 1 other identifier: STMU2020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Myocardium; Injury; Myocardial Infarction; Myocardial Ischemia

Keywords

colchicine; outcome: myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Major cardiovascular adverse events (number of events)

  This outcome will be assessed using a questionnaire. The following headings will be used: * Cardiovascular death (number of events) * Non-fatal myocardial infarction (number of events) * Resuscitated cardiac arrest (number of events) * Hospitalization for unstable angina (number of events) For each heading, the total number of events will be recorded and the numbers will all be added to calculate 'Major Adverse Cardiovascular Events' in form of number of events. This outcome has no specific values of measure but a discrete numerical value

  3 months

Secondary Outcomes (3)

• Troponin I (ng/ml)

  3 months

• Creatine Kinase-Myocardial Band (IU/L)

  3 months

• C-reactive protein (mg/L)

  3 months

Study Arms (2)

Colchicine Group

ACTIVE COMPARATOR

This group will receive low dose colchicine, 0.5 mg.

Drug: Colchicine

Placebo group

PLACEBO COMPARATOR

This group will receive a placebo drug with a similar shape and mass as that to experimental drug

Drug: Placebo oral tablet

Interventions

Colchicine DRUG

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

Colchicine Group

Placebo oral tablet DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shifa Tameer-e-Millat University: lead
• Rawalpindi Institute of Cardiology: collaborator

Study Sites (1)

Rawalpindi Institute of Cardiology

Rawalpindi, 46000, Pakistan

Location

Related Publications (35)

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MeSH Terms

Conditions

Wounds and Injuries; Myocardial Infarction; Myocardial Ischemia

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Nismat Javed, MBBS (2021)

  Shifa College of Medicine, Shifa Tameer-e-Millat University

  PRINCIPAL INVESTIGATOR

• Jahanzeb Malik, MBBS (2011)

  Rawalpindi Institute of Cardiology

  STUDY DIRECTOR

• Adeel ur Rehman, MBBS, FCPS

  Rawalpindi Institute of Cardiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 1, 2020
• First Posted: January 6, 2020
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)