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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
Sponsor:
Information provided by:
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Stroke, Acute Drug: DFIL Drug: NINDS Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hospice Care
Drug Information available for: Alteplase

Arm Intervention/treatment
Experimental: DFIL Drug: DFIL
Alteplase : 0.8mg/kg over 90 minutes

Active Comparator: NINDS Drug: NINDS
Alteplase : 0.9mg/kg over 60 minutes




Primary Outcome Measures :
  1. Modified Rankin score [ Time Frame: day 90 ]


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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
France
Hôpital Pierre Wertheimer
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Paul TROUILLAS, MD Hospices Civils de Lyon

Responsible Party: Pr Paul TROUILLAS, Service de Neurologie, Hôpital Neurologique, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00132509     History of Changes
Other Study ID Numbers: 2000.208
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: February 2009

Keywords provided by Hospices Civils de Lyon:
rt-PA
thrombolysis
Acute ischemic stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases