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

Primary Purpose

Stroke, Acute

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
DFIL
NINDS
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring rt-PA, thrombolysis, Acute ischemic stroke

Eligibility Criteria

18 Years - 81 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpital Pierre Wertheimer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DFIL

NINDS

Arm Description

Outcomes

Primary Outcome Measures

Modified Rankin score

Secondary Outcome Measures

Full Information

First Posted
August 19, 2005
Last Updated
July 21, 2011
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT00132509
Brief Title
FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke
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 Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Terminated
Why Stopped
End of promotion by the sponsor
Study Start Date
September 2001 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
rt-PA, thrombolysis, Acute ischemic stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DFIL
Arm Type
Experimental
Arm Title
NINDS
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
DFIL
Intervention Description
Alteplase : 0.8mg/kg over 90 minutes
Intervention Type
Drug
Intervention Name(s)
NINDS
Intervention Description
Alteplase : 0.9mg/kg over 60 minutes
Primary Outcome Measure Information:
Title
Modified Rankin score
Time Frame
day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul TROUILLAS, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pierre Wertheimer
City
Bron
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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