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

NCT00132509 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2011-07-22

No results posted yet for this study

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.

Conditions

  • Stroke, Acute

Interventions

DRUG

DFIL

Alteplase : 0.8mg/kg over 90 minutes

DRUG

NINDS

Alteplase : 0.9mg/kg over 60 minutes

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Paul TROUILLAS, MD · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00132509 on ClinicalTrials.gov