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

This study has been terminated.
(End of promotion by the sponsor)
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00132509
First received: August 19, 2005
Last updated: July 21, 2011
Last verified: February 2009
History of Changes
  Purpose

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 Intervention Phase
Stroke, Acute
 Drug: DFIL
Drug: NINDS
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

MedlinePlus related topics: Hospice Care
Drug Information available for: Alteplase
U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Modified Rankin score [ Time Frame: day 90 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: September 2001
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DFIL Drug: DFIL
Alteplase : 0.8mg/kg over 90 minutes
Active Comparator: NINDS Drug: NINDS
Alteplase : 0.9mg/kg over 60 minutes

  Eligibility

Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 19, 2005
Last Updated: July 21, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 19, 2013