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

Korábbi kezelés

• Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting)
• Previous known allergy to TNK
• Major surgery in past 30 days
• History of acute ischemic stroke in the last 60 days and/or has received previous treatment with a thrombolytic within the last 90 days
• Concurrent enrollment in another trial that could confound the results of this study

Más betegség

• Imaging evidence of hemorrhage or mass effect at baseline
• 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
• Any terminal medical condition with life expectancy less than 6 months

Laborértékek

• Platelet count <100,000
• Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR >1.7

Egyéb

• Premorbid modified Rankin scale (mRS) score >1
• Active hemorrhagic diathesis, or known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
• Pregnant or lactating
• Patient is on or requires dialysis
• Presumed septic embolus; suspicion of bacterial endocarditis
• Suspicion of aortic dissection
• Intracranial neoplasm
• Patient is unlikely to return for 90-day follow-up.
• Intravenous tissue plasminogen activator (tPA) administered concurrently with Intra-arterial TNK

• 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