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The study objective is to evaluate the safety and efficacy of Intra arterial (IA) Tenecteplase (TNK) as an adjunctive therapy in acute ischemic stroke (AIS) patients with large vessel occlusions (LVO) in the anterior circulation of Internal Carotid Artery (ICA), Middle Cerebral Arteries (M1 and M2) who achieve a reperfusion grade of Modified Treatment in Cerebral Ischemia Scale (mTICI) 2b or higher post-mechanical thrombectomy using Food and Drug Administration (FDA) approved devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized to Intra Arterial (IA) Tenecteplase (TNK) | Experimental | Patients will receive IA- TNK |
|
| Randomized to best medical practice | No Intervention | Patients will receive best medical practice treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tenecteplase | Drug | Patients treated with standard of care mechanical thrombectomy (MT) that achieved mTICI 2b or higher revascularization. Patients will be randomized into one of two arms: IA TNK or control. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint- Modified Rankin Scale (mRS) | Proportion of patients with Modified Rankin Scale (mRS) 0-1 at 90-days. The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6). | 90 days (+/- 30 days) post treatment. |
| Primary Safety Endpoint- Incidence of Intracranial hemorrhage and Neurologic Worsening | Incidence of any intracranial hemorrhage and neurologic worsening of at least 4 points on the National Institute of Health Stroke Scale (NIHSS) associated with a Parenchymal hematoma, Type 2 (PH2) brain hemorrhage, according to the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) criteria, within 24 (±12) hours from randomization. | 24 hours (+/-12 hours) post treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal Modified Rankin Scale (mRS) | Ordinal mRS at 90 day. The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6). | 90 days (+/-30 days) post treatment. |
| Functional Independence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Syed Fazal Zaidi, MD | Contact | (419)- 291-8027 | Syed.Zaidi2@utoledo.edu | |
| Tanya Siddiqui | Contact | 4192913498 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProMedica Toledo Hospital | Recruiting | Toledo | Ohio | 43606 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39772606 | Result | Zaidi SF, Castonguay AC, Zaidat OO, Jadhav AP, Sheth SA, Haussen DC, Nguyen TN, Burgess RE, Alhajala HS, Gharaibeh K, Salahuddin H, Rao R, Oliver MJ, Jumaa MA. Safety of Adjunctive Intraarterial Tenecteplase Following Mechanical Thrombectomy: The ALLY Pilot Trial. Stroke. 2025 Feb;56(2):355-361. doi: 10.1161/STROKEAHA.124.048846. Epub 2025 Jan 8. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D000208 | Acute Disease |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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Proportion of patients with functional independence, defined as a mRS of 0-2 at 90 days. |
| 90 days (+/- 30 days) post treatment. |
| Final Revascularization Grade | Final revascularization grade at end of IA treatment among those with less than mTICI 3 prior to IA-TNK administration. | Immediate post treatment. |
| Mortality rate at 90 days | Mortality rate at 90-days | Mortality rate at 90-days (+/- 30 days) post treatment. |
| Mortality Rate at discharge | Mortality rate at discharge. | Day 6 (+/-1 day) or Discharge post treatment. |
| Infarct Volume Post Procedure | Infarct volume on post-procedure follow-up scans performed at 24 ± 12 hours following mechanical thrombectomy. | 24 hours (+/- 12 hours) post treatment. |
| Asymptomatic Intracranial hemorrhage | Incidence of any asymptomatic intracranial hemorrhage | 24 hours (+/- 12 hours) post treatment. |
| Mean Number of Boluses | Mean number of boluses to achieve improvement in reperfusion to mTICI 2c and mTICI 3 among those without mTICI3 prior to IA-TNK administration. | Immediate post procedure. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |