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

Recruiting now · Phase 2/Phase 3

Conditions studied: Ischemic Stroke, Acute Disease

In brief

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.

Key facts

Study ID

NCT06949228

Run by

ProMedica Health System

People needed

132

Starts

2025-07-30

Expected to finish

2028-05-30

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-85
• Anterior circulation ischemic stroke symptoms with confirmed occlusion (ICA, M1, or M2) on angiogram and mechanical thrombectomy initiated within 24 hours since last known well
• Alberta Stroke Program Early CT Score (ASPECTS) Score ≥6 on baseline Non-contrast Head 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

You may not qualify if…

• 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 within the last 48 hours, or INR >1.7
• Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical 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 the patient from participating
• Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation
• Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) that is refractory to treatment
• History of acute ischemic stroke in the last 60 days and/or has received previous treatment 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 with Intra-arterial TNK

Where it is running

• ProMedica Toledo Hospital — Toledo, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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