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

Stroke, Acute Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00132509
• Other study ID #: 2000.208
• Status: Terminated
• Phase: Phase 2
• First received: August 19, 2005
• Last updated: July 21, 2011
• Start date: September 2001
• Est. completion date: August 2008

Study information

• Verified date: February 2009
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 500
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 81 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Drug:
• DFIL
Alteplase : 0.8mg/kg over 90 minutes
• NINDS
Alteplase : 0.9mg/kg over 60 minutes

Locations

Country	Name	City	State
France	Hôpital Pierre Wertheimer	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin score		day 90	Yes