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| Tracking Information | |||||
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| First Received Date ICMJE | August 19, 2005 | ||||
| Last Updated Date | June 11, 2008 | ||||
| Start Date ICMJE | September 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Modified Rankin score at day 90 | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00132509 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | FRALYSE Trial: Comparison of the Classical rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke | ||||
| Official Title ICMJE | 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 | ||||
| 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 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. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Active Control Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
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| Condition ICMJE | Stroke, Acute | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Estimated Enrollment ICMJE | 500 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 81 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00132509 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 2000.208 | ||||
| Study Sponsor ICMJE | Hospices Civils de Lyon | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hospices Civils de Lyon | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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