FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke
Terminated
Phase 2 ResultsEligibility 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
View Trial Locations
Recruitment
- Enrollment: 500
- Gender: Both
- Minimum Age: 18 Years
- Accepts Healthy Volunteers: Yes
- 1 location, 1 country
Principal Investigator
- Paul TROUILLAS, MD
Hospices Civils de Lyon
