Repeated IV tenecteplase for ischemic stroke within 3 hours of onset

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study enrolls adults with acute ischemic stroke who received standard IV tenecteplase within 3.0 hours of onset and have NIHSS ≥4 but show no significant improvement one hour after treatment with intracranial hemorrhage excluded. Eligible participants who remain eligible can receive a second IV tenecteplase dose within 4.5 hours of onset as a rescue therapy. The primary objective is to test the safety and feasibility of this repeated thrombolysis approach, and secondary analyses will explore early recanalization rates and longer-term functional outcomes. Patients planned for endovascular therapy or with major bleeding risk or significant white-matter disease are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 year;
* Acute ischemic stroke within 3 hours of onset, having received standard intravenous thrombolysis;
* Measurable neurological deficit before the first intravenous thrombolysis, with NIHSS ≥ 4;
* No significant clinical improvement (reduction in NIHSS ≤ 2) or neurological deterioration after initial improvement at 1 hour after the first thrombolysis, with intracranial hemorrhage ruled out by neuroimaging;
* The second intravenous thrombolysis can be administered within 4.5 hours of onset;
* First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
* Signed informed consent.

Exclusion Criteria:

* Planed for endovascular treatment;
* Significant cerebral white matter hyperintensities (Fazekas score 3)；
* Any coagulation abnormality before the first thrombolysis, including INR \> 1.5；
* Pregnancy；
* Allergy to the investigational drug(s)；
* Receipt of dual antiplatelet therapy within 24 hours prior to thrombolysis;
* Comorbidity with other serious diseases;
* Participating in other clinical trials within 3 months;
* Patients not suitable for the study considered by researcher.

Where it's running

• Yu Cui
  Shenyang, None Selected, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.