Local Versus Systemic Thrombolysis for Acute Ischemic Stroke (SYNTHESIS)

PHASE3CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

January 31, 2008

Study Completion Date

January 31, 2008

Conditions
StrokeCerebrovascular Accident
Interventions
DRUG

local interarterial recombinant tissue plasminogen activator

Endovascular treatment must be performed asap after random.and definitely within 6h from symp. onset.It includes intrarterial thrombolysis with rt-PA,if necessary,associated to or substituted by mechanical clot disruption and/or retrieval.Fibrinolytic therapy should be performed within 1h,the full dose of rt-PA infusion should not exceed 0.9 mg/kg (max 90 mg in the case of body weight ≥100 kg).If a complete recanalization is achieved,rt-PA infusion can be interrupted before reaching the maximum dosage.The option of performing a thrombolysis by mechanical means to obtain a mechanical disintegration/shift/detach/fissure of the thrombus and/or a retraction/aspiration can be considered on the basis of the type,location and characteristics of the occlusion.These choices may involve the use of the microguidewire as a mechanical instrument to favour the disintegration of the thrombus,using systems to capture the thrombus by extraction or more complex systems to crush and aspirate the thrombus

DRUG

intravenous (IV) rt-PA

IV thrombolytic treatment is started immediately after randomization, within 4.5 h of symptoms onset. IV rt-PA is administered at a dose of 0.9 mg/kg (max 90 mg), 10% of which is given as a bolus, followed by the delivery of the remaining 90% as a constant infusion over 60 mins

Trial Locations (1)

20162

AO Ospedale Niguarda Ca' Granda, Milan

All Listed Sponsors
lead

Niguarda Hospital

OTHER

NCT00540527 - Local Versus Systemic Thrombolysis for Acute Ischemic Stroke (SYNTHESIS) | Biotech Hunter | Biotech Hunter