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

Civil Hospices of Lyon

Status and phase

Terminated

Phase 2

Conditions

Stroke, Acute

Treatments

Drug: DFIL

Drug: NINDS

Study type

Interventional

Funder types

Other

Identifiers

NCT00132509

2000.208

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 81 years old

Volunteers

Accepts Healthy Volunteers

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