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Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake

Study acronym: DO-IT
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Trial sites expanded: 102 → 109 locations
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 3 of 3 entries
  2. Trial sites expanded: 14 → 102 locationsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 31, 2024 to Mar 14, 2025
    • Study sites: 13 to 14
    v3
  4. Interventions: Tenecteplase and Alteplase (Drug) to Tenecteplase or Alteplase (Drug)v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
DO-IT is an international, multicenter, prospective, two-arm, randomized, open label, blinded endpoint superiority trial determining the safety and efficacy of intravenous thrombolysis (IVT) in participants experiencing an acute ischemic stroke (AIS) with recent (within the last 48 hours) intake of direct oral anticoagulant (DOAC). For this purpose, 906 adult participants experiencing an AIS with recent DOAC intake will be enrolled at several high-volume international stroke centers and randomly assigned in a ratio of 1:1 to one of two treatment arms: (1) IVT and standard of care/best medical treatment or (2) standard of care/best medical treatment. The DO-IT trial is a definitive test of the hypothesis that IVT is superior to standard of care for achieving better outcome at 90 days in AIS participants with recent DOAC intake.
Trial Details
NCT Number NCT06571149
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Conditions
(from sponsor)		 Ischemic Stroke
Related terms Ischemic Stroke
Enrollment 906 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov