FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke
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|ClinicalTrials.gov Identifier: NCT00132509|
Recruitment Status : Terminated (End of promotion by the sponsor)
First Posted : August 22, 2005
Last Update Posted : July 22, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Acute||Drug: DFIL Drug: NINDS||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
Alteplase : 0.8mg/kg over 90 minutes
|Active Comparator: NINDS||
Alteplase : 0.9mg/kg over 60 minutes
- Modified Rankin score [ Time Frame: day 90 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132509
|Hôpital Pierre Wertheimer|
|Bron, France, 69677|
|Principal Investigator:||Paul TROUILLAS, MD||Hospices Civils de Lyon|