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

July 21, 2011 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69677
        • Hopital Pierre Wertheimer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modified Rankin score
Time Frame: day 90
day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Paul TROUILLAS, MD, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

August 19, 2005

First Submitted That Met QC Criteria

August 19, 2005

First Posted (Estimate)

August 22, 2005

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 21, 2011

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000.208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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