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

Phase 2

Terminated

• Conditions: Stroke, Acute
• Interventions: Drug: NINDS; Drug: DFIL

• Registration Number: NCT00132509
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2005-08-19
• Study First Submitted QC: 2005-08-19
• Study First Posted: 2005-08-22
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-02
• Last Update Submitted: 2011-07-21
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NINDS	NINDS	-
DFIL	DFIL	-

Primary Outcome Measures

Name	Time	Method
Modified Rankin score	day 90

Trial Locations

Locations (1)

Hôpital Pierre Wertheimer; 🇫🇷 Bron, France