Aortic & peripheral vascular diseaseRandomised controlled trial

Long-term colchicine for the prevention of vascular recurrent events in non-cardioembolic stroke (CONVINCE): a randomised controlled trial

LancetPublished

  • Randomised controlled trial
  • parallel-group
  • open-label
  • blinded endpoint assessment
  • two prespecified interim analyses

Ended early due to budget constraints attributable to the COVID-19 pandemic

Authors' conclusion

Although no statistically significant benefit was observed on the primary intention-to-treat analysis, the findings provide new evidence supporting the rationale for anti-inflammatory therapy in further randomised trials.

Study context

Population
Hospital-based patients with non-severe, non-cardioembolic ischaemic stroke or high-risk TIA3,144 in ITT analysis
Participants
3,154 patients
Comparison
Long-term colchicine plus usual care vs usual care only
  • Colchicine and usual caren = 1,569
  • Usual care alonen = 1,575reference
Primary endpoint
Composite of:
  • First fatal or non-fatal recurrent ischaemic stroke
  • MI
  • Cardiac arrest
  • Hospitalisation for unstable angina

Primary result

As reported in the abstract

Hazard ratio

0.84

95% CI 0.68–1.05

P = 0.12

Events by treatment group

Colchicine and usual care vs Usual care alone
HR 0.84 (95% CI 0.68–1.05); P = 0.12

Further findings

C-reactive protein · 28 days and 1, 2 and 3 years

Lower C-reactive protein (CRP) with colchicine at all timepoints (no difference at baseline)
P < 0.05

Safety

Serious adverse events

Rates similar in both groups

Original publication

Long-term colchicine for the prevention of vascular recurrent events in non-cardioembolic stroke (CONVINCE): a randomised controlled trial. Lancet. Published 7 June 2024. doi:10.1016/s0140-6736(24)00968-1

Summarised from the published abstract; every number is checked against it