TESPI
Thrombolysis in Elderly Stroke Patients in Italy
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Purpose:
To collect efficacy and safety data on alteplase (rt-PA) in patients aged more than 80 years old, to demonstrate that the treatment of these patients within 3 hours of ischemic stroke onset with rt-PA compared to patients receiving standard treatment, will result in an improved clinical outcome with a favourable benefit/risk ratio.
Year Started:
2008
Year Presented:
2007
Design:
National, multicenter, randomized, open label vs standard treatment controlled trial in Italy.
Inclusion Criteria
Male and female stroke patients aged = or > 80 years with onset of symptoms < 3 hours.
Exclusion Criteria
NIHSS > 17 on admission, baseline blood glucose <50 or > 200 mg/dl (values up to 300 mg/dl are allowed, if they can be reduced to < 200 mg/dl before treatment), ordinary contraindications for thrombolysis, evidence of intracranial haemorrhage on admission CT-scan, any history of prior clinical stroke and concomitant diabetes
Patient Involvement:
Patients will be randomized 1:1 to receive intravenous rt-PA (alteplase 0.9 mg/kg bodyweight, maximally 90mg; 10% bolus plus one hour infusion) or standard treatment, according to national (SPREAD) guidelines, started within 3 hours from the onset of stroke.
For the treatment of severe bleeding at a non-compressible site or for the reversal of fibrinolysis during study drug administration, appropriate measures according to the patient needs should be taken after stopping the infusion of trial medication. All patients will receive a CT between 22 and 36 hours to exclude complications. Other CT scans are optional and must be performed only in case of clinical deterioration. Antithrombotics are disallowed during the first 24 hours. Follow-up will take place at 2 hours, 24 hours, 7 days (or discharge, or transfer), and performed by a blind assessor at 90 days.
Primary Outcome:
Primary efficacy endpoint: patients (%) with favourable outcome at day 90, according to modified Rankin Scale (mRS) 0-2.
Safety endpoints: patient survival at Day 90, stroke-related and neurological deaths, adverse events recording, cerebral herniation rate, symptomatic edema, vital sign measurement, symptomatic intracerebral haemorrhage at the 22-36 hours post-treatment scan combined with neurological deterioration leading to an increase of 1 or more points on the NIH Stroke Scale.
Secondary Outcome:
At days: 0 (2 hours after treatment), 1, 7
- NIHSS (total score), mean/median change from baseline
At day: 7
- NIHSS: improvement of >= 4 points or score 0-1
At day 90:
- mRS (total score) (median); Barthel Index (total score) (median).
- Glasgow Outcome Score 1-2
Stratified endpoint of NIHSS and mRS
Baseline NIHSS < 8: mRS 0 response
Baseline NIHSS 8-14: mRS 0-2 response
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Source of Information:
EudraCT number: 2007-006177-88
Presented at the 5th Mediterranean Neuroscience Congress (September 2007).
Presented at the 2008 Italian Stroke Conference (February, 2008).
Presented at the Congress of the Italian Medicines Agency, for the Drug approval and vigilance (AIFA) (October 2009
Presented at the 6th World Stroke Congress (September 2008).
Presented at the Italian Neurogerontology Congress (December 2008).
Presented at the Congress of the Italian Medicines Agency, for the Drug approval and vigilance (AIFA) (October 2009).
Publications
Intravenous thrombolysis with rt-PA in acute stroke patients aged >80 years. Letters in Drug Design & Discovery, 2008; 5: 209-213.
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Web Links and Publications:
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This information last updated on: 5/14/2010
Reviewed on: 05/24/2010.
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