FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke

Study Overview
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Brief Summary
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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 protocol to test this hypothesis. Moreover, the therapeutic window is 7 hours. Rt-PA (alteplase) is injected intravenously in the 2 arms of the study for a duration of 60 minutes in the arm with a classical dose and 90 minutes in the arm with a low dose-longer infusion. This is a study of the outcome at 90 days.

Official Title
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Comparison of the Classical Rt-PA Procedure (0.9mg/kg Over 60 Minutes) With a Longer Procedure With Lower Dose (0.8mg/kg Over 90 Minutes) in Acute Ischemic Stroke

Conditions
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Stroke, Acute

Intervention / Treatment
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* Drug: DFIL
* Drug: NINDS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DFIL<br> | Drug: DFIL<br>* Alteplase : 0.8mg/kg over 90 minutes<br>|
| Active Comparator: NINDS<br> | Drug: NINDS<br>* Alteplase : 0.9mg/kg over 60 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin score |  | day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rt-PA, thrombolysis, Acute ischemic stroke