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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00132509
Other study ID # 2000.208
Secondary ID
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


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
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