NCT00640367

Intra-arterial Versus Systemic Thrombolysis for Acute Ischemic Stroke

Synthesis Expansion: A Randomized Controlled Trial on Intra-Arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Niguarda Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

SYNTHESIS is a pragmatic multicenter randomized controlled trial (RCT), open-label, with blinded follow-up aiming to determine whether loco-regional intra-arterial (IA) with recombinant tissue-plasminogen activator (rt-PA) and/or mechanical devices, as compared with systemic intravenous (I.V.) infusion of rt-PA within 3 hours of ischemic stroke, increases the proportion of independent survivors at 3 months.

Detailed description

Eligibility criteria:patients with symptomatic, CT verified, acute ischemic stroke, being able to initiate IV rt-PA within 3 hours and IA thrombolysis within 6 hours of stroke onset, when uncertainty about appropriateness the two approaches exists as established by the treating physician. Eligible patients are randomized to receive either 0.9 mg/kg (max 90 mg) IV rt-PA (control arm) or up to 0.9 mg/Kg IA rt-PA (max 90 mg) over 60 minutes into the thrombus, eventually associated with clot mechanical disaggregation/dislocation or retraction/aspiration. Mechanical thrombolysis is possible also without the use of rt-PA. The procedural choices of the interventional neuroradiologist depend on the type of occlusion, circumstances and experience. The study is designed to detect or disprove (alpha=5% and power probability=80%) a 15% absolute difference between the treatment groups in the percentage of patients with a favourable outcome (Modified Rankin Scale Score = 0-1).Enrollment will be completed with 350 randomized patients. Neurological deficit will be scored with NIH Stroke Scale at day 7 or discharge, or transfer to another hospital, whichever occurs first.Patient's clinical condition will be again evaluated by a telephone call after 90 days.

Conditions

• Stroke
• Cerebrovascular Accident

Interventions

Type	Name	Description
OTHER	Alteplase IA and/or mechanical thrombolysis	loca intra-arterial recombinant tissue plasminogen activator and/or mechanical thrombolysis
DRUG	Alteplase IV	intravenous recombinant tissue plasminogen activator

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-02-01
• Completion: 2012-07-01
• First posted: 2008-03-21
• Last updated: 2014-04-25

Locations

1 site across 1 country: Italy