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To date, the time window of intravenous thrombolysis is limited within 4.5 hours of stroke onset. Although EXTEND study has proved that intravenous thrombolysis can be extended from 4.5 to 9 hours, but the eligible patients must be selected by CTP. Thus, it is of clinical importance how to extend the time window of intravenous thrombolysis, which can benifit more patients. The current trial aims to investigate the effect of intravenous thrombolysis with TNK from 4.5 to 6 hours in ischemic stroke with help of Butyphthalide, which was found to be neuroprotective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNK group | Experimental | intravenous thrombolysis with 0.25 mg/kg TNK, with the biggest dose of 25 mg |
|
| control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNK-Tissue Plasminogen Activator | Drug | 0.25 mg TNK thrombolysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| symptomatic intracerebral hemorrhage | any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase) | 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of excellent prognosis (mRS 0-1) | the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome | Day 90 |
| The proportion of favourable prognosis (mRS 0-2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, General Hospital of Northern Theater Command | Shenyang | 110016 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38238620 | Derived | Chen HS, Chen MR, Cui Y, Shen XY, Zhang H, Lu J, Zhao LW, Duan YJ, Li J, Wang YM, Min LQ, Zhao LH, Wan LS, Zhang ZH, Nguyen TN. Tenecteplase Plus Butyphthalide for Stroke Within 4.5-6 Hours of Onset (EXIT-BT): a Phase 2 Study. Transl Stroke Res. 2025 Jun;16(3):575-583. doi: 10.1007/s12975-024-01231-2. Epub 2024 Jan 19. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C104096 | TNK-tissue plasminogen activator |
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the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
| Day 90 |
| Distribution of modified Rankin Score | the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome | Day 90 |
| Changes in National Institute of Health stroke scale (NIHSS) | the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome | 24 hours, 2 weeks |
| any intracerebral hemorrhage | the evidence of bleeding on the head CT scan | 36 hours |
| any cerebral microbleeding(CMB) | CMB is measured by SWI sequence | 48 hours |
| infarct volume | infarct volume is measured by DWI sequence | 48 hours |
| proportion of death | death due to any cause | Day 90 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |