Repeat tenecteplase for early ischemic stroke with medium or large vessel blockage

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 tests a rescue strategy of repeated intravenous tenecteplase in patients with imaging-confirmed medium or large vessel occlusion who do not show significant improvement one hour after standard thrombolysis. Eligible adults must have received standard-dose IV thrombolysis within 4.5 hours, have measurable deficits (NIHSS ≥4) and acceptable baseline imaging scores (ASPECTS/pc-ASPECTS ≥6 or Pontine-Midbrain Index ≤2). Follow-up vascular imaging at one hour must confirm persistent occlusion and exclude intracranial hemorrhage before administering a second tenecteplase dose. The goal is to increase early recanalization and clinical improvement, particularly where endovascular therapy is not planned or available.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 year;
* Acute ischemic stroke presumably caused by large or medium vessel occlusion within 4.5 hours of onset, having received standard-dose intravenous thrombolysis, and with no planned thrombectomy;
* Measurable neurological deficit before the first intravenous thrombolysis, with NIHSS ≥ 4;
* Baseline pc-ASPECTS/ASPECTS ≥ 6, and for posterior circulation infarction, a Pontine-Midbrain Index ≤ 2 (assessed by CT or DWI);
* No significant clinical improvement (reduction in NIHSS ≤ 2) or neurological deterioration after initial improvement at 1 hour after the first thrombolysis;
* Follow-up imaging (CTA or MRA) at 1 hour after the first thrombolysis rules out intracranial hemorrhage and confirms the presence of large or medium vessel occlusion (internal carotid artery, M1-M3 segments of the middle cerebral artery, A1-A3 segments of the anterior cerebral artery, P1-P3 segments of the posterior cerebral artery, basilar artery or V4 segment of the vertebral artery, PICA, AICA, or SCA);
* The second intravenous thrombolysis can be administered within 6 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 white matter hyperintensities (Fazekas score 3);
* Any coagulation abnormality before the first thrombolysis, including INR \> 1.5;
* Receipt of dual antiplatelet therapy within 24 hours prior to thrombolysis.；
* Pregnancy；
* Allergy to the investigational drug(s)；
* 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

• Lu Wang
  Shenyang, Liaoning, 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.