Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke

Summary

This study evaluates the use of Colchicine in adults over 40 years of age who have suffered an ischaemic stroke or transient ischaemic attack NOT caused by cardiac embolism or other defined causes. Patients will be randomised to 0.5 mg/day of Colchicine plus usual care, or to usual care alone.

To investigate the efficacy of low dose colchicine (0.5mg/day) plus usual care (defined as antiplatelet, lipid-lowering, antihypertensive treatment, and appropriate lifestyle advice) compared with usual care alone to prevent non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, hospitalization for unstable angina and vascular death after ischaemic stroke or transient ischaemic attack (TIA) not caused by cardiac embolism or other defined causes unrelated to atherosclerosis

Conditions

• Ischemic Attack, Transient
• Stroke

Interventions

DRUG

Colchicine

Sponsors & Collaborators

• Health Research Board, Ireland

  collaborator OTHER

• Irish Heart Foundation

  collaborator OTHER

• University of Limerick

  collaborator OTHER

• University of Edinburgh

  collaborator OTHER

• National University of Ireland, Galway, Ireland

  collaborator OTHER

• Universitat de Lleida

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• University College Dublin

  lead OTHER

Principal Investigators

• Prof Peter Kelly · Mater Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-12

Primary Completion

2024-01-31

Completion

2024-01-31

Countries

• Belgium
• Canada
• Czechia
• Denmark
• Estonia
• Germany
• Ireland
• Lithuania
• Netherlands
• Poland
• Portugal
• Spain
• Switzerland
• United Kingdom

Study Locations