Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke (ATTIS)
Acute Ischemic Stroke
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
Eligibility Criteria
Inclusion Criteria: Age 18-80 years Ischemic stroke with measurable deficit on NIH Stroke Scale Treatment within 4.5 hours of stroke onset Be able to engage in daily life independently before the onset of this ischemic stroke (mRS score: 0-1) Patients awakening with symptoms are defined by the time last observed normal Written informed consent by patient or proxy Exclusion Criteria: Patients with premorbid modified Rankin Scale (mRS) score ≥3 Patients for whom a complete NIH Stroke Score cannot be obtained Hemiplegic migraine with no arterial occlusion on CTA Seizure at stroke onset and no visible occlusion on baseline CTA Intracranial haemorrhage on baseline CT Clinical presentation suggesting subarachnoid haemorrhage even if baseline CT is normal Large areas of hypodense ischaemic changes on baseline CT Patients with systolic blood pressure >185 mm Hg or diastolic blood pressure >110 mm Hg Female, pregnant or breast feeding Known bleeding diathesis Known allergic to tirofiban or other glycoprotein IIb/IIIa antagonist Use of oral anticoagulants and International Normalized Ratio (INR) ≥1,4 Use of new oral anticoagulants (NOAC) within the last 12 hours Heparin <48 hours and increased Activated partial thromboplastin tike (APTT) Low molecular weight heparin(oid) <24 hours Any other investigational drug <14 days Sepsis Patients with arterial puncture at a noncompressible site or lumbar puncture <7 days Major surgery or serious trauma <14 days Gastrointestinal or urinary tract hemorrhage <14 days Clinical stroke <2 months History of intracranial haemorrhage Brain neurosurgery <2 months Serious head trauma <2 months Pericarditis Any serious medical illness likely to interact with treatment Confounding pre-existent neurological or psychiatric disease Unlikely to complete follow-up Pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Tenecteplase plus Tirofiban
Tenecteplase plus Placebo
Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over ~10 seconds). Patients will receive a continuous intravenous infusion of tirofiban at a rate of 0.1 µg/kg per minute for 26.5 h after start of tenecteplase treatment within 90 min, if there was no parenchymal hemorrhage or extensive subarachnoid hemorrhage beyond the Sylvian fissure on the posttreatment computed tomography scan. Aspirin (100 mg/d) will be given orally at 4 hours before the end of infusion and continued for at least 3 months after intravenous thrombolysis .
Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over ~10 seconds). Patients will receive a continuous intravenous infusion of placebo at a rate of 0.1 µg/kg per minute for 26.5 h after start of tenecteplase treatment within 90 min, if there was no parenchymal hemorrhage or extensive subarachnoid hemorrhage beyond the Sylvian fissure on the posttreatment computed tomography scan. Aspirin (100 mg/d) will be given orally at 4 hours before the end of infusion and continued for at least 3 months after intravenous thrombolysis .