Thrombolysis in Elderly Stroke Patients in Italy "TESPI"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Interventions

Trial Design

National, multicenter, randomized, open label vs standard treatment controlled trial in Italy.

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 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

Sponsors

No-profit study founded by the AIFA - Agenzia Italiana del Farmaco (Italian Medicines Agency, for the Drug approval and vigilance)