Intra-arterial Versus Systemic Thrombolysis for Acute Ischemic Stroke (SYNTHESIS EXP)
|ClinicalTrials.gov Identifier: NCT00640367|
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : April 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Stroke Cerebrovascular Accident||Other: Alteplase IA and/or mechanical thrombolysis Drug: Alteplase IV||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Synthesis Expansion: A Randomized Controlled Trial on Intra-Arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||July 2012|
Experimental: IA thrombolysis
IA recombinant tissue plasminogen activator and/or mechanical thrombolysis
Other: Alteplase IA and/or mechanical thrombolysis
loca intra-arterial recombinant tissue plasminogen activator and/or mechanical thrombolysis
Active Comparator: IV rtPA
IV recombinant tissue plasminogen activator
Drug: Alteplase IV
intravenous recombinant tissue plasminogen activator
- To assess whether IA thrombolysis, as compared to IV rt-PA, increases survival free of disability (modified Rankin score of zero or 1) at 3 months. [ Time Frame: 3 months ]
- To asses whether IA thrombolysis vs.IV rt-PA 1.improves the 7 day neurological deficit; 2.is safe on the base of symptomatic intracranial hemorrhages, fatal and non-fatal stroke, death from any cause, neurological deterioration within 7 days [ Time Frame: 7 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640367
|A.O. Ospedale Ca' Granda|
|Milan, Italy, 20162|
|Principal Investigator:||Alfonso Ciccone, MD||A.O. Ospedale Niguarda Ca' Granda|