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

This study has been terminated.

( End of promotion by the sponsor )

First Received on August 19, 2005. Last Updated on July 21, 2011 History of Changes

Sponsor:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00132509

Purpose

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.

Condition	Intervention	Phase
Stroke, Acute	Drug: DFIL Drug: NINDS	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hospice Care

Drug Information available for: Alteplase Tissue-type plasminogen activator

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Modified Rankin score [ Time Frame: day 90 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	September 2001
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: DFIL	Drug: DFIL Alteplase : 0.8mg/kg over 90 minutes
Active Comparator: NINDS	Drug: NINDS Alteplase : 0.9mg/kg over 60 minutes

Eligibility

Ages Eligible for Study:	18 Years to 81 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132509

Locations

France
Hôpital Pierre Wertheimer
Bron, France, 69677

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Paul TROUILLAS, MD

Hospices Civils de Lyon

More Information

No publications provided

Responsible Party:	Pr Paul TROUILLAS, Service de Neurologie, Hôpital Neurologique, Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00132509 History of Changes
Other Study ID Numbers:	2000.208
Study First Received:	August 19, 2005
Last Updated:	July 21, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

rt-PA
thrombolysis
Acute ischemic stroke

Additional relevant MeSH terms:

Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on February 09, 2012