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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00132509

Enrollment

500

Registered

2005-08-22

Start date

2001-09-30

Completion date

2008-08-31

Last updated

2011-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Acute

Keywords

rt-PA, thrombolysis, Acute ischemic stroke

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.

Interventions

DRUGDFIL

Alteplase : 0.8mg/kg over 90 minutes

DRUGNINDS

Alteplase : 0.9mg/kg over 60 minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 81 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Modified Rankin score	day 90

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026