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

This study has been suspended.

First Received: August 19, 2005 Last Updated: June 11, 2008 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: alteplase 0.9mg/kg over 60 minutes Drug: alteplase 0.8mg/kg over 90 minutes	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
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 at day 90

Estimated Enrollment:	500
Study Start Date:	September 2001

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

Study ID Numbers:	2000.208
Study First Received:	August 19, 2005
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00132509 History of Changes
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:

Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Hematologic Agents
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents

Cardiovascular Agents
Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Fibrin Modulating Agents
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Brain Infarction

ClinicalTrials.gov processed this record on February 08, 2010