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

NCT00132509 | Terminated Phase 2

• 1 other identifier: 2000.208
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute

Keywords

rt-PA; thrombolysis; Acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

• Modified Rankin score

  day 90

Study Arms (2)

DFIL

EXPERIMENTAL

Drug: DFIL

NINDS

ACTIVE COMPARATOR

Drug: NINDS

Interventions

DFIL DRUG

Alteplase : 0.8mg/kg over 90 minutes

DFIL

NINDS DRUG

Alteplase : 0.9mg/kg over 60 minutes

NINDS

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Pierre Wertheimer

Bron, 69677, France

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

National Institute of Neurological Disorders and Stroke (U.S.)

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

National Institutes of Health (U.S.); Academies and Institutes; Organizations; Health Care Economics and Organizations; United States Public Health Service; United States Dept. of Health and Human Services; United States Government Agencies; Federal Government; Government

Study Officials

• Paul TROUILLAS, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 22, 2005
• Study Start: September 1, 2001
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: July 22, 2011

Record last verified: 2009-02

Locations

FR (1)