Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the effect of intravenous tenecteplase plus endovascular thrombectomy (EVT) compared to EVT alone on 4.5 to 24 hours after stroke due to basilar artery occlusion.
Background and Rationale: Recently, two prospective multicenter RCT (ATTENTION and BAOCHE trials) have shown a significantly beneficial effect of EVT in patients with an acute symptomatic basilar artery occlusion. The EXTEND-IA TNK trial demonstrated that intravenous thrombolysis with tenecteplase is superior to alteplase before EVT for anterior circulation large vessel occlusion strokes. However, it is unclear whether intravenous tenecteplase bridging with EVT is superior to EVT alone in the extended window patients with basilar artery occlusion. Therefore, additional studies are needed to explore the potential benefit of intravenous tenecteplase in these patients.
Study design: Multicenter, prospective, controlled clinical trial with open-label treatment and blind outcome assessment (PROBE) of intravenous tenecteplase plus EVT versus EVT alone. The trial has observer blinded assessment of the primary outcome and neuroimaging at baseline and follow up.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous tenecteplase+endovascular thrombectomy | Experimental | Patients will receive intravenous tenecteplase (0.25mg/kg, max 25mg) plus endovascular thrombectomy. |
|
| Endovascular thrombectomy alone | Active Comparator | Patients will receive endovascular thrombectomy alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenecteplase | Drug | Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds) before endovascular thrombectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with modified Rankin Score 0-2 at day 90 (±14 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 (± 14 days) after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with modified Rankin Score 0-3 at day 90 (±14 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 (± 14 days) after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Overall mortality at 7 (± 2 days) and 90 (± 14 days) | evaluate death rate | 7 (± 2 days) and 90 (± 14 days) after procedure |
| Symptomatic intracerebral hemorrhage (sICH) within 72 hours | SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 72 hours or any hemorrhage leading to death |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wei Hu, MD | The First Affiliated Hospital of University of Science and Technology of China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Hefei | Anhui | 230001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41946560 | Derived | Li R, Nguyen T, Tao C, Sun J, Xu P, Luo C, Wang L, Liu T, Song J, Jing X, Wang A, Qureshi AI, Abdalkader M, Saver JL, Nogueira RG, Hu W. Intravenous tenecteplase before endovascular thrombectomy in patients with acute basilar artery occlusion within 4.5-24 hours: study protocol and rationale. Stroke Vasc Neurol. 2026 Apr 7:svn-2025-004275. doi: 10.1136/svn-2025-004275. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Endovascular thrombectomy | Procedure | The choice of endovascular thrombectomy strategy will be made by the treating neurointerventionist. All thrombectomy devices for endovascular treatment, which are approved by CFDA for this purpose, are allowed in the trial. |
|
|
| Ordinal Shift analysis of modified Rankin Score at day 90 (±14 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 (± 14 days) after procedure |
| Score on the NIHSS at 24 hours | The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit. | 24 hours after procedure |
| Score on the NIHSS at 5-7 days or discharge | The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit. | 5-7 days or discharge after procedure |
| Proportion of patients with modified Rankin Score 0-1 at day 90 (±14 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 (± 14 days) after procedure |
| Proportion of patients with modified Rankin Score 0-4 at day 90 (±14 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 (± 14 days) after procedure |
| Score on the EuroQoL 5-dimensions 5-level (EQ5D-5L) at 90 days (±14 days) | Health-related quality of life, assessed with EQ-5D-5L | 90 (± 14 days) after procedure |
| level of activities of daily living (Barthel index, BI) at 90 days (±14 days) | Level of activities of daily living | 90 (± 14 days) after procedure |
| Successful reperfusion (Extended thrombolysis in cerebral infarction [eTICI] score 2b50-3) on digital substraction angiography (DSA) prior to thrombectomy | Evaluate effect of intravenous thrombolysis on reperfusion | within 5 minutes at angiography |
| Successful reperfusion on final angiography of thrombectomy | Evaluate effect of thrombectomy on reperfusion | Within 5 minutes at final angiography of thrombectomy |
| Successful recanalization on CT or MR angiography within 72 hours | Evaluate vascular patency after treatment | Within 72 hours after procedure |
| Infarct volume (Posterior Circulation Acute Stroke Prognosis Early Computed Tomography Score, PC-ASPECTS) evaluated on CT or MRI within 72 hours | PC-ASPECTS=10 indicates a normal scan, PC-ASPECTS=0 indicates early ischemic changes or hypoattenuation in all above territories. 1 or 2 points each are subtracted for early ischemic changes or hypoattenuation in: left or right thalamus, cerebellum or posterior cerebral artery territory, respectively (1 point); any part of midbrain or pons (2 points) | Within 72 hours after procedure |
| Within 72 hours after procedure |
| Any intracerebral hemorrhage within 72 hours | Evaluate intracerebral hemorrhage | Within 72 hours after procedure |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| C104096 | TNK-tissue plasminogen activator |
| D017131 | Thrombectomy |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided