NCT02898610: CONVINCE

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

Completed Phase 3 Last updated 13 March 2025

What this trial tests

Phase 3 trial testing Colchicine in Ischemic Attack, Transient in 3,154 participants. Completed in 31 January 2024.

Timeline

12 December 2016

Primary endpoint
31 January 2024

31 January 2024

Quick facts

Lead sponsor	University College Dublin
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	3,154
Start date	12 December 2016
Primary completion	31 January 2024
Estimated completion	31 January 2024
Sites	145 locations across Denmark, Netherlands, Belgium, Estonia, Ireland, Germany, Poland, United Kingdom

Drugs / interventions tested

• Colchicine (COLCHICINE) — full drug profile →

Conditions studied

• Ischemic Attack, Transient — all drugs for Ischemic Attack, Transient →
• Stroke — all drugs for Stroke →

Sponsor

University College Dublin

Who can join

40 and older, any sex, with Ischemic Attack, Transient or Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting inflammation in atherosclerosis - from experimental insights to the clinic.
   Soehnlein O, Libby P. · · 2021 · cited 723× · PMID 33976384 · DOI 10.1038/s41573-021-00198-1
2. Therapeutic strategies targeting inflammation and immunity in atherosclerosis: how to proceed?
   Engelen SE, Robinson AJB, Zurke YX, Monaco C. · · 2022 · cited 308× · PMID 35102320 · DOI 10.1038/s41569-021-00668-4
3. Colchicine in Cardiovascular Disease: In-Depth Review.
   Deftereos SG, Beerkens FJ, Shah B, Giannopoulos G, et al · · 2022 · cited 213× · PMID 34965168 · DOI 10.1161/circulationaha.121.056171
4. Systemic inflammation after stroke: implications for post-stroke comorbidities.
   Simats A, Liesz A. · · 2022 · cited 179× · PMID 35971650 · DOI 10.15252/emmm.202216269
5. Macrophages in cardiovascular diseases: molecular mechanisms and therapeutic targets.
   Chen R, Zhang H, Tang B, Luo Y, et al · · 2024 · cited 169× · PMID 38816371 · DOI 10.1038/s41392-024-01840-1
6. Colchicine and the heart.
   Imazio M, Nidorf M. · · 2021 · cited 143× · PMID 33961006 · DOI 10.1093/eurheartj/ehab221
7. Inflammation as a Therapeutic Target in Atherosclerosis.
   Nguyen MT, Fernando S, Schwarz N, Tan JT, et al · · 2019 · cited 116× · PMID 31357404 · DOI 10.3390/jcm8081109
8. Targeting the Inflammasome in Cardiovascular Disease.
   Olsen MB, Gregersen I, Sandanger Ø, Yang K, et al · · 2022 · cited 114× · PMID 35128212 · DOI 10.1016/j.jacbts.2021.08.006