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The goal of this clinical trial is to evaluate whether intra-arterial (IA) rhTNK-tPA thrombolysis can improve neurological outcomes in acute large vessel occlusion patients after successful mechanical thrombectomy (MT) recanalization between 4.5- 24 hours from symptom onset. Participants enrolled will be randomly assigned to study or control arm with a 1:1ratio. Study group will receive IA rhTNK-tPA thrombolysis (0.125 mg/kg, Max 12.5mg) plus best medical management, and control receive best medical management alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNK group | Experimental | Patients of this group will receive IA rhTNK-tPA plus Best Medical Management (BMM) after successful mechanical thrombectomy (MT) recanalization |
|
| control group | Active Comparator | Patients of this group will receive Best Medical Management (BMM) alone after successful mechanical thrombectomy (MT) recanalization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA) | Drug | The administration of rhTNK-tPA will be infused constant and slowly over 15min (0.125 mg/kg, Max 12.5mg) through a microcatheter. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of excellent outcome | Rate of 90 (±7) day modified Rankin scale (mRS) 0-1 | 90±7 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of sICH (Heidelberg Bleeding Classification) | Rate of sICH (Heidelberg Bleeding Classification) | within 48 hours after randomization |
| Volume of Tmax>6s | 24 hours (±12 hours) after randomization |
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Inclusion Criteria:
Clinical Inclusion Criteria:
Neuroimaging Inclusion Criteria:
Exclusion Criteria:
Clinical Exclusion Criteria:
Specific Neuroimaging Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaochuan Huo, Dr. | Contact | +8613716292262 | huoxiaochuan@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40616323 | Derived | Miao Z, Luo G, Song L, Sun D, Chen W, Yao X, Pan Y, Liu Y, Yuan G, Wen C, Wei M, Cai X, Yang Q, Zhou Z, Chang M, Nan G, Wang J, Xiang G, Zhou L, Gao W, Zhang H, Hao J, Xu C, Sun Y, Yi T, Feng G, Han H, Gao F, Ma N, Mo D, Sun X, Deng Y, Tong X, Li X, Jia B, Wang B, He Z, Yang M, Zhao X, Zhang X, Zhang L, Li S, Tong X, Jing J, Xiong Y, Liu T, Li Z, Ren Z, Wang Y, Liebeskind DS, Jovin TG, Nguyen TN, Wang Y, Liu L, Yan B, Huo X; ANGEL-TNK Investigators. Intra-arterial Tenecteplase for Acute Stroke After Successful Endovascular Therapy: The ANGEL-TNK Randomized Clinical Trial. JAMA. 2025 Aug 19;334(7):582-591. doi: 10.1001/jama.2025.10800. | |
| 39357896 |
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|
| Best Medical Management | Other | Best Medical Management |
|
| Infarct core volume change from baseline | Infarct core volume change from baseline, assessed with NCCT at 7 days (±1 day) after randomization/at discharge or with MRI at 36 hours (±12 hours) | 7 days (±1 day) after randomization/at discharge or at 36 hours (±12 hours) after randomization |
| mRS (shift analysis) | mRS (shift analysis) | 90 days (±7 days) after randomization |
| Rate of good outcome | Rate of mRS 0-2 | 90 days (±7 days) after randomization |
| Rate of mRS 0-3 | Rate of mRS 0-3 | 90 days (±7 days) after randomization |
| NIHSS 0-1 or decrease ≥10 from baseline NIHSS | NIHSS 0-1 or decrease ≥10 from baseline NIHSS | 36 hours (±12hours) after randomization |
| EQ-5D-5L score | EQ-5D-5L score | 90 days (±7 days) after randomization |
| All-caused mortality | All-caused mortality | 90 days (±7 days) after randomization |
| Rate of any intracranial hemorrhage (Heidelberg Bleeding Classification) | Rate of any intracranial hemorrhage (Heidelberg Bleeding Classification) | within 48 hours after randomization |
| Derived |
| Huo X, Luo G, Sun D, Nguyen T, Abdalkader M, Chen W, Yao X, Yuan G, Yi T, Han H, Pan Y, Jovin TG, Liebeskind DS, Liu L, Zhao X, Ren Z, Wang Y, Wang Y, Yan B, Miao Z. Intra-arterial tenecteplase after successful endovascular therapy (ANGEL-TNK): protocol of a multicentre, open-label, blinded end-point, prospective, randomised trial. Stroke Vasc Neurol. 2025 Aug 26;10(4):508-513. doi: 10.1136/svn-2024-003318. |
| 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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