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This study aims to evaluate the efficacy and safety of tenecteplase (TNK) intravenous thrombolysis within the extended time window (4.5 to 24 hours) in patients with acute posterior circulation ischemic stroke.
This multicenter, prospective, randomized, controlled trial assesses the efficacy and safety of intravenous tenecteplase for acute posterior-circulation ischemic stroke treated 4.5-24 hours after onset. Participants with imaging-confirmed stroke will be randomly assigned 1:1 to receive either tenecteplase or standard medical therapy. Eligible patients must present within 4.5-24 hours from symptom onset, defined as the midpoint between last known normal and first observed neurological deficit. All participants will undergo telephone follow-up at 3 months and 1 year, with the modified Rankin Scale as the primary outcome measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard medical management | Active Comparator | standard medical management |
|
| TNK plus standard medical treatment | Experimental | Patients in the TNK treatment group will receive TNK intravenous thrombolysis and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNK plus standard medical treatment | Drug | Patients in the TNK treatment group will receive TNK intravenous thrombolysis and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with modified Rankin Scale (mRS) score 0-1 at 90 ±14 days; | 90 ±14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with mRS score 0-2 at 90 ±14 days; | 90 ±14 days | |
| Proportion of patients with mRS score 0-3 at 90 ±14 days; | 90 ±14 days | |
| Ordinal distribution of mRS score at 90 ±14 days; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Hu MD,PhD | Contact | +86055162284313 | andinghu@ustc.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of the University of Science and Technology of China | Recruiting | Hefei | China |
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| standard medical management | Drug | standard medical management |
|
| 90 ±14 days |
| Change in NIHSS score at 24-36 hours post-treatment | 24 hours post-treatment |
| 5)Change in NIHSS score at 5-7 days post-treatment; | 5-7 days post-treatment |
| EQ-5D-5L questionnaire score at 90 ±14 days; | 90 ±14 days |
| Barthel Index score at 90 ±14 days; | 90 ±14 days |
| 1)Symptomatic intracranial hemorrhage within 36 hours (Heidelberg criteria) | 24-36 hours after treatment |
| Any intracranial hemorrhage within 36 hours (Heidelberg criteria) | 24-36 hours after treatment |
| Mortality rate at 90 ±14 days | 90 ±14 days |
| Overall incidence of serious adverse events | 90 ±14 days |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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