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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
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.
ProMedica Toledo Hospital
Toledo, Ohio, United States
RECRUITINGPrimary 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).
Time frame: 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.
Time frame: 24 hours (+/-12 hours) post treatment.
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).
Time frame: 90 days (+/-30 days) post treatment.
Functional Independence
Proportion of patients with functional independence, defined as a mRS of 0-2 at 90 days.
Time frame: 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.
Time frame: Immediate post treatment.
Mortality rate at 90 days
Mortality rate at 90-days
Time frame: Mortality rate at 90-days (+/- 30 days) post treatment.
Mortality Rate at discharge
Mortality rate at discharge.
Time frame: 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.
Time frame: 24 hours (+/- 12 hours) post treatment.
Asymptomatic Intracranial hemorrhage
Incidence of any asymptomatic intracranial hemorrhage
Time frame: 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.
Time frame: Immediate post procedure.
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