FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke
Stroke, Acute
About this trial
This is an interventional treatment trial for Stroke, Acute focused on measuring rt-PA, thrombolysis, Acute ischemic stroke
Eligibility Criteria
Inclusion Criteria: Symptoms of ischemic stroke Presence of a deficit measurable with National Institutes of Health Stroke Scale (NIHSS) Lack of any hemorrhagic lesion on the computed tomography (CT) scan at entry Time of therapy less than 7 hours after onset of stroke Permanent or aggravating symptoms Ages 18-81 Exclusion Criteria: Lack of cerebral infarction or of cranial trauma within 3 weeks before therapy No surgery within 14 days before therapy History of cerebral bleeding Blood pressure: systolic >185 mmHg and/or diastolic >110 mmHg Minor symptoms or symptoms rapidly improving Gastro-intestinal or urinary hemorrhage within 21 days Arterial puncture within 7 days before therapy Epileptic seizure at the beginning of stroke Patients under oral anticoagulants or having received heparin within 48 hours, and with elevated activated partial thromboplastin time (aPTT) Patients with elevated International Normalized Ratio (INR) or thrombocyte count < 100 x 10^9 Blood glucose value < 2.7 mmol/l or > 22.2 mmol/l Cardiac, pulmonary, hepatic or renal failure, not allowing a study over 3 months History of gastric ulcer within 15 days; gestation and menstruation
Sites / Locations
- Hôpital Pierre Wertheimer
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
DFIL
NINDS