Status:
TERMINATED
FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Stroke, Acute
Eligibility:
All Genders
18-81 years
Phase:
PHASE2
Brief Summary
Data from the literature have suggested that a longer time of thrombolysis might be more effective in ischemic stroke. We, the investigators at Hospices Civils de Lyon, have designed a randomized prot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00132509
Start Date
September 1 2001
End Date
August 1 2008
Last Update
July 22 2011
Active Locations (1)
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1
Hôpital Pierre Wertheimer
Bron, France, 69677