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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 suspended.
Study NCT00132509   Information provided by Hospices Civils de Lyon
First Received: August 19, 2005   Last Updated: June 11, 2008   History of Changes

August 19, 2005
June 11, 2008
September 2001
 
Modified Rankin score at day 90
Same as current
Complete list of historical versions of study NCT00132509 on ClinicalTrials.gov Archive Site
 
 
 
FRALYSE Trial: Comparison of the Classical rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke
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

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.

 
Phase II
Interventional
Allocation:  Randomized
Control:  Active Control
Intervention Model:  Parallel Assignment
Masking:  Single Blind
Primary Purpose:  Treatment
Stroke, Acute
  • Drug: alteplase 0.9mg/kg over 60 minutes
  • Drug: alteplase 0.8mg/kg over 90 minutes
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Suspended
500
 
 

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
Both
18 Years to 81 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00132509
 
2000.208
Hospices Civils de Lyon
 
Principal Investigator: Paul TROUILLAS, MD Hospices Civils de Lyon
Hospices Civils de Lyon
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP