Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial

Phase

2/3

Condition

Stroke

Blood Clots

Cerebral Ischemia

Treatment

tenecteplase

Clinical Study ID

NCT06949228

ALLY II

Ages 18-85
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age 18-85
Anterior circulation ischemic stroke symptoms with confirmed occlusion (ICA, M1, orM2) on angiogram and mechanical thrombectomy initiated within 24 hours since lastknown well
Alberta Stroke Program Early CT Score (ASPECTS) Score ≥6 on baseline Non-contrastHead CT (NCCT)
Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or higher.
Ability to obtain signed informed consent prior to randomization from LAR or Subject

Exclusion

Exclusion Criteria:

Premorbid modified Rankin scale (mRS) score >1
Imaging evidence of hemorrhage or mass effect at baseline
Platelet count <100,000
Active hemorrhagic diathesis, or known hereditary or acquired hemorrhagic diathesis,coagulation factor deficiency
Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken withinthe last 48 hours, or INR >1.7
Patients requiring active treatment with dual antiplatelet agents (e.g. proximalcervical carotid artery stenting)
Pregnant or lactating
Previous known allergy to TNK
Major surgery in past 30 days
Patient is on or requires dialysis
History of intracranial hemorrhage or serious head trauma at any time
Any condition in the opinion of the enrolling physician that would preclude thepatient from participating
Pre-existing medical, neurological, or psychiatric disease that would confound theneurological or functional evaluation
Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolicblood pressure >110 mmHg) that is refractory to treatment
History of acute ischemic stroke in the last 60 days and/or has received previoustreatment with a thrombolytic within the last 90 days
Presumed septic embolus; suspicion of bacterial endocarditis
Suspicion of aortic dissection
Intracranial neoplasm
Any terminal medical condition with life expectancy less than 6 months
Concurrent enrollment in another trial that could confound the results of this study
Patient is unlikely to return for 90-day follow-up.
Intravenous tissue plasminogen activator (tPA) administered concurrently withIntra-arterial TNK

Study Design