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Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years later Dec 15, 2026 → Dec 15, 2029
See other at-risk trials from General Hospital of Shenyang Military Region

Record History

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  1. Primary and study completion pushed from Dec 15, 2026 to Dec 15, 2029v7
  2. Primary and study completion dates: Dec 15, 2025 to Dec 15, 2026v6
  3. Primary and study completion dates: Mar 15, 2025 to Dec 15, 2025
    • Enrollment target: 1250 to 1440
    • Eligibility criteria expanded, about 23 words
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Jan 30, 2024 to Feb 1, 2024
    v4
  5. Start date: Sep 15, 2023 to Jan 30, 2024
    • Eligibility criteria revised
    • Secondary endpoints revised (11)
    • Study title shortened, about 2 words
    v3
  6. Re-verified, no change to tracked fieldsv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To date, the benefit of intravenous thrombolysis is confined within 4.5 hours of onset for acute ischemic stroke (AIS) patients without advanced neuroimaging selection. Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of intravenous tenecteplase (TNK) in AIS within 4.5 to 6 hours of onset. The current study aims to investigate the efficacy and safety of TNK for AIS within 4.5 to 6 hours of onset.
Trial Details
NCT Number NCT06010628
Lead Sponsor General Hospital of Shenyang Military Region
Conditions
(from sponsor)		 Stroke, Ischemic
Related terms Ischemic Stroke
Enrollment 1,440 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov