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Rationale: Recently, one prospective multicenter RCT reported a potential beneficial effect of intra-arterial alteplase following successful endovascular thrombectomy (EVT) in patients with an acute intracranial large vessel occlusion. In 2018, another prospective multicenter RCT supported the superiority of tenecteplase over alteplase in ischemic stroke patients with large vessel occlusion.
Objective: To assess the effect of EVT in addition to intra-arterial tenecteplase compared to EVT alone, in patients with large vessel occlusion of posterior circulation, on functional and safety outcomes.
Study design: This is a parallel group, randomized clinical trial of EVT with IA-TNK versus EVT. The trial has observer blind assessment of the primary outcome and of neuro-imaging at baseline and follow-up.
Study population: Patients with acute intracranial large vessel occlusion of posterior circulation and an eTICI 2b-3 after EVT.
Main study parameters/outcomes: The primary effect parameter will be excellent functional status at day 90 defined as a modified Rankin Score (mRS) of 0-1. The estimate will be adjusted for the known prognostic variables age, pre-stroke mRS, time from onset to randomization, stroke severity (NIHSS) and collaterals and adjusted and unadjusted estimates with corresponding 95% confidence intervals will be reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endovascular thrombectomy | Active Comparator | For patients randomized to the control group, EVT has to be completed within 24 hours of stroke onset. The choice of EVT strategy will be made by the treating neurointerventionalist. All mechanical thrombectomy devices for EVT, which are approved by CFDA for this purpose, are allowed in the trial. |
|
| endovascular thrombectomy+intra-arterial tenecteplase | Experimental | For patients randomized to the endovascular treatment arm, tenecteplase will be injected according to protocol, proceeding to inject TNK through a distal access catheter or microcatheter located proximal to the residual thrombus (if still present) and distally to the origin of the lenticulostriates branches. The administration of TNK will be infused for 15 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenecteplase | Drug | If patients are randomized and assigned to receive intra-arterial tenecteplase thrombolysis, tenecteplase will be injected according to protocol, proceeding to inject TNK through a distal access catheter or microcatheter located proximal to the residual thrombus (if still present) and distally to the origin of the pontine arteries. |
| Measure | Description | Time Frame |
|---|---|---|
| a modified Rankin Score of 0-1 | 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 |
|---|---|---|
| a modified Rankin Score of 0-3 | 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 |
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Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine | Hefei | Anhui | 239300 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40674670 | Derived | Hu W, Nguyen TN, Qureshi M, Chen Z, Tao C, Li R, Yi TY, Feng G, Su J, Cui T, Cao Z, Wang H, Zeng G, Yuan G, Jing X, Luo C, Zhu Y, Qureshi AI, Nogueira RG, Liu X, Abdalkader M. Noncontrast CT vs CT Perfusion Imaging in Patients With Basilar Artery Occlusion: Analysis of the ATTENTION and ATTENTION IA Trials. Neurology. 2025 Aug 12;105(3):e213911. doi: 10.1212/WNL.0000000000213911. Epub 2025 Jul 17. | |
| 39809509 |
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|
| endovascular thrombectomy alone | Other | Patients will receive randomization if the eTICI score on cerebral angiography is 2b-3 and will stop the procedure if they have been assigned to the control group. |
|
| Modified Rankin Score |
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 |
| NIHSS score | 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 |
| mortality | (Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100% | 90 (± 14 days) after procedure |
| symptomatic intracerebral hemorrhage (ICH) | 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. | within 72 hours after procedure |
| Derived |
| Hu W, Tao C, Wang L, Chen Z, Li D, Chen W, Yi T, Xu L, Yu C, Wang T, Yao X, Cui T, Yuan G, Su J, Chen L, Zhou Z, Ma Z, Wang J, Wang B, Han H, Wang H, Chen J, Zhou P, Cao Z, Ren Y, Cai X, Shi H, Zhang G, Yu L, Yuan X, Li J, Zeng G, Ni C, Li T, Wu Y, Li Y, Li K, Liu Y, Wang Y, Jin Y, Liu H, Wen J, Sun J, Zhu Y, Li R, Zhang C, Liu T, Song J, Wang L, Cheng J, Qureshi AI, Nguyen TN, Saver JL, Nogueira RG, Liu X. Intra-arterial tenecteplase after successful endovascular recanalisation in patients with acute posterior circulation arterial occlusion (ATTENTION-IA): multicentre randomised controlled trial. BMJ. 2025 Jan 14;388:e080489. doi: 10.1136/bmj-2024-080489. |
| 38124230 | Derived | Tao C, Li R, Sun J, Zhu Y, Wang L, Zhang C, Liu T, Song J, Qureshi AI, Abdalkader M, Nguyen TN, Saver JL, Nogueira RG, Hu W. Intra-arterial tenecteplase following endovascular therapy in patients with acute posterior circulation arterial occlusion: study protocol and rationale. J Neurointerv Surg. 2024 Dec 26;17(e1):e68-e73. doi: 10.1136/jnis-2023-021076. |
| 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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| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| 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 |
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