FRALYSE Trial: Comparison of the Classical rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke
Information source: Hospices Civils de Lyon
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke, Acute
Intervention: alteplase 0.9mg/kg over 60 minutes (Drug); alteplase 0.8mg/kg over 90 minutes (Drug)
Phase: Phase 2
Status: Suspended
Sponsored by: Hospices Civils de Lyon Official(s) and/or principal investigator(s):
Paul TROUILLAS, MD, Principal Investigator, Affiliation: Hospices Civils de Lyon
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.
Clinical Details
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 design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Primary outcome: Modified Rankin score at day 90
Eligibility
Minimum age: 18 Years.
Maximum age: 81 Years.
Gender(s): Both.
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
Locations and Contacts
Hôpital Pierre Wertheimer, BRON 69677, France
Additional Information
Starting date: September 2001
Last updated: June 11, 2008
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