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This study is designed to investigate the efficacy and safety of intravenous tenecteplase before interhospital transfer from a non-endovascular capable center(nECC) to an endovascular capable center (ECC) for thrombectomy in patients with acute ischemic stroke (AIS) caused by neuroimaging-confirmed acute basilar artery occlusion (BAO) between 4.5-24 hours of symptom onset.
This is a multicenter, prospective, open-label, blinded endpoint (PROBE), randomized controlled trial in patients with acute ischemic stroke due to BAO first presenting to a nECC and intending to undertake thrombectomy in an ECC.
Patients will be required to have occlusion of the basilar artery on baseline computed tomography angiography (CTA)/magnetic resonance angiography (MRA) at the nECC. Patients will be randomized to either intravenous tenecteplase (0.25mg/kg, maximum 25mg)or not before interhospital transfer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group | Experimental | Patients will receive intravenous Tenecteplase 0.25 mg/kg body-weight up to a maximum of 25mg before the interhospital transfer or the physician departure. A single bolus dose should be administered over 5-10 seconds based on patient weight. Transfer to ECCs or physician travelling for thrombectomy should be initiated immediately after Tenecteplase administration. |
|
| Control group | No Intervention | Patients will receive standard treatment and be directly transferred to ECCs or transfer physician for EVT according to Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenecteplase thrombolysis | Drug | Patients will receive intravenous Tenecteplase 0.25 mg/kg body-weight up to a maximum of 25mg before the transfer. A single bolus dose should be administered over 5-10 seconds based on patient weight. Transfer to ECCs for thrombectomy should be initiated immediately after Tenecteplase administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Dichotomized mRS of 0-2 vs. 3-6 | Dichotomized mRS of 0-2 vs. 3-6 at 90±7 days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) | 90±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal mRS score | Ordinal mRS score at 90 (±7) days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) | 90 (±7) days |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic intracranial hemorrhage （sICH） | Incidence of sICH (Heidelberg criteria) measured at 36 hours | 36 hours |
| Parenchymal hematoma type 2 (PH2) | Incidence of PH2 at 36h |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junwei Hao, MD | Contact | 01083198277 | haojunwei@vip.163.com | |
| Gaoting Ma, MD | Contact | 01083198082 | demo_doctor@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Junwei Hao, MD | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | China |
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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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|
| Dichotomized mRS of 0-1 vs. 2-6 |
Dichotomized mRS of 0-1 vs. 2-6 at 90 (±7) days |
| 90 (±7) days |
| Dichotomized mRS of 0-3 vs. 4-6 | Dichotomized mRS of 0-3 vs. 4-6 at 90 (±7) days | 90 (±7) days |
| Early dramatic clinical response rate | Early dramatic clinical response rate at 24 (±12) h, defined as a NIHSS score of 0 or 2 or NIHSS drop of ≥8 from baseline | 24 (±12) hours |
| Arterial recanalization during interhospital transfer | Arterial recanalization during interfacility transfer, evaluated with the angiography (CTA/MRA/first run of DSA) at ECC | At ECC before thrombectomy or physician-arrival |
| Successful reperfusion | Successful reperfusion at end-of-procedure angiography, defined as expanded Treatment in Cerebral Infarction (eTICI) score of 2b, 2c, or 3 on angiography | At end-of-procedure angiography (up to 15 minutes) |
| First pass excellent reperfusion | First pass reperfusion defined as eTICI 2c or greater after the first thrombectomy pass | Immediately after the thrombectomy |
| Arterial recanalization | Arterial recanalization at 24(±12)h, evaluated with CTA/MRA | 24(±12) hours |
| EQ-5D-5L | Score on the EQ-5D-5L at 90 (±7) days;(EQ-5D-5L: Minimum Score 5, Maximum score 25, lower scores mean a better quality of life). | 90 (±7) days |
| 36 hours |
| All cause mortality | All-cause mortality up to 90 (±7) days. | 90 (±7) days. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |