Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)
Recruiting
Phase 4
Interventional Study
Stroke, Ischemic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,440 (estimated)
- Sponsor
- General Hospital of Shenyang Military Region · Other
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About This Trial
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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 year
* Acute ischemic stroke confirmed by non-contrast computed tomography and use of CTA for assessment of LVO as determined by local investigators;
* The time from last known well to treatment: 4.5 - 6 hours;
* NIHSS ≥ 4 at randomization;
* First stroke onset or pas…
Contacts
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