Tenecteplase Compared to Alteplase for Patients With Large Vesel Oclusion Suspicion Before Thrombectomy
Acute Ischemic Stroke
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring acute ischemic stroke, large vessel occlusion
Eligibility Criteria
Inclusion Criteria: Patients eligible to undergo intravenous thrombolysis (tPA or TNK) within 4.5 hours after the onset of ischemic stroke. Suspicion of Cerebral vascular occlusion on brain imaging. Age >18 years old Men and women (women with child-bearing potential are excluded, unless pregnancy test negative/ confirmed menstrual period/ postmenopausal or hysterectomy). A new focal disabling neurologic deficit consistent with acute cerebral ischemia. Informed consent obtained from subject or acceptable subject surrogate (i.e. next of kin, or legal representative), or Differed Inform Consent (DIC) to avoid any delay in the initiation of iv thrombolysis. The DIC will be sign by the patient or next of kin at any time after the tPA or TNK treatment is started. Exclusion criteria: Patients with severe preexisting disability, defined as a modified Rankin scale score >3. Glasgow Coma Scale score ≤ 7. Known hemorrhagic diathesis, coagulation factor deficiency, or antivitamin K oral anticoagulant therapy with INR >3.0. Subjects on factor Xa inhibitors (e.g. apixaban) or direct thrombin inhibitors are eligible for participation. Severe, sustained and uncontrollable hypertension (systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg). Serious, advanced, or terminal illness with anticipated life expectancy of less than 3 months. Patients that are unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas). Patient participating in a randomized study, involving an investigational drug or device that would impact this study. Suspicion of aortic dissection presumed septic embolus, or suspicion of bacterial endocarditis. Imaging exclusion criteria: Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories. Cerebral vasculitis. CT or MRI evidence of hemorrhage Significant mass effect with midline shift. Evidence of intracranial tumor. Subjects with known occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
Sites / Locations
- Hospital Universitari Vall d'HebronRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Tenecteplase (TNK)
Alteplase (tPA)
Drug: Alteplase (tPA) Dose: 0.9 mg/kg Route: Intravenous (IV) infusion
Drug: Tenecteplase (TNK) Dose: 0.25 mg/kg Route: Intravenous (IV) bolus injection