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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2008-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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DFIL

Group Type EXPERIMENTAL

DFIL

Intervention Type DRUG

Alteplase : 0.8mg/kg over 90 minutes

NINDS

Group Type ACTIVE_COMPARATOR

NINDS

Intervention Type DRUG

Alteplase : 0.9mg/kg over 60 minutes

Interventions

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DFIL

Alteplase : 0.8mg/kg over 90 minutes

Intervention Type DRUG

NINDS

Alteplase : 0.9mg/kg over 60 minutes

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes