Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenec
Despite being the standard pharmacological reperfusion therapy for acute ischemic stroke, intravenous thrombolysis is limited by suboptimal recanalization rates. Tenecteplase (TNK), a newer thrombolytic agent, offers practical advantages over alteplase, including single bolus administration. However, a significant prop
| Condition(s) | Ischemic Stroke |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Despite being the standard pharmacological reperfusion therapy for acute ischemic stroke, intravenous thrombolysis is limited by suboptimal recanalization rates. Tenecteplase (TNK), a newer thrombolytic agent, offers practical advantages over alteplase, including single bolus administration. However, a significant proportion of patients fail to achieve early clinical improvement after standard thrombolysis, likely due to persistent vessel occlusion. This study proposes to investigate a rescue strategy for patients who do not show significant neurological improvement within one hour after receiving standard intravenous tenecteplase within 3 hours of stroke onset. The primary objective is to evaluate the safety and feasibility of administering a second dose of tenecteplase in this scenario. |
| Who can participate | 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 be |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | General Hospital of Shenyang Military Region |
| Locations | Shenyang, None Selected, China |
| Start date | 2026-03-25 |
| NCT ID | NCT07375953 |
| Official listing | https://clinicaltrials.gov/study/NCT07375953 |