Colchicine for Prevention of Vascular Inflammation in Non-Cardioembolic Stroke - CONVINCE

Jun 27, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Health Research Board Ireland, German Research Foundation, and Research Foundation Flanders, Belgium.
Date Published:
05/16/2024
Original Posted Date:
06/27/2024
References

Contribution To Literature:

The CONVINCE trial failed to show that long-term colchicine prevents recurrent adverse events after ischemic stroke or TIA.

Description:

The goal of the trial was to evaluate long-term colchicine compared with usual care among patients with nonsevere ischemic stroke or transient ischemic attack (TIA).

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients with nonsevere ischemic stroke or TIA were randomized to colchicine 0.5 mg daily (n = 1,569) vs. usual care (n = 1,575).

  • Total number of enrollees: 3,144
  • Duration of follow-up: 36 months
  • Mean patient age: 66 years
  • Percentage female: 31%
  • Percentage with diabetes: 23%

Inclusion criteria:

  • Patients ≥40 years old
  • Nonsevere ischemic stroke or high-risk TIA

Exclusion criteria:

  • Atrial fibrillation, other cardiac embolism, or other cause of stroke such as arterial dissection
  • Significant renal, liver, or blood disorder
  • Peripheral neuropathy, myopathy, inflammatory bowel disease, or chronic diarrhea

Principal Findings:

The primary outcome, composite of first fatal or nonfatal recurrent ischemic stroke, myocardial infarction, cardiac arrest, or hospitalization, was 9.8% in the colchicine group vs. 11.7% in the usual care group (p = 0.12).

Secondary outcomes:

  • Serious adverse events: 69.9% with colchicine vs. 70.8% with usual care
  • Loose stools or diarrhea: 12.1% with colchicine vs. 2.0% with usual care

Interpretation:

Among patients with nonsevere ischemic stroke or high-risk TIA, long-term colchicine failed to prevent recurrent adverse events. The trial finished before the anticipated number of outcomes accrued due to budget constraints from the COVID-19 pandemic. Serious adverse events were similar between treatment groups, although colchicine was associated with a higher frequency of loose stools or diarrhea.

References:

Kelly P, Lemmens R, Weimar C, et al. Long-term colchicine for the prevention of vascular recurrent events in non-cardioembolic stroke (CONVINCE): a randomized controlled trial. Lancet 2024;Jun 7:[Epub ahead of print].

Clinical Topics: Vascular Medicine, Prevention

Keywords: Colchicine, Ischemic Attack, Transient, Ischemic Stroke


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