Intra-arterial Versus Systemic Thrombolysis for Acute Ischemic Stroke (SYNTHESIS EXP)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00640367 |
Recruitment Status
:
Completed
First Posted
: March 21, 2008
Last Update Posted
: April 25, 2014
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | March 18, 2008 | |||
First Posted Date ICMJE | March 21, 2008 | |||
Last Update Posted Date | April 25, 2014 | |||
Study Start Date ICMJE | February 2008 | |||
Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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 ] | |||
Original Primary Outcome Measures ICMJE |
To assess whether local IA r-PA, 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 ] | |||
Change History | Complete list of historical versions of study NCT00640367 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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 ] | |||
Original Secondary Outcome Measures ICMJE |
1. IA rt-PA vs.IV rt-PA improves the 7 day neurological deficit. 2. IA rt-PA vs.IV rt-PA 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 ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Intra-arterial Versus Systemic Thrombolysis for Acute Ischemic Stroke | |||
Official Title ICMJE | Synthesis Expansion: A Randomized Controlled Trial on Intra-Arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke | |||
Brief 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. |
|||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE |
|
|||
Intervention ICMJE |
|
|||
Study Arms |
|
|||
Publications * | Ciccone A, Valvassori L, Nichelatti M, Sgoifo A, Ponzio M, Sterzi R, Boccardi E; SYNTHESIS Expansion Investigators. Endovascular treatment for acute ischemic stroke. N Engl J Med. 2013 Mar 7;368(10):904-13. doi: 10.1056/NEJMoa1213701. Epub 2013 Feb 6. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
350 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | July 2012 | |||
Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
COMPUTED TOMOGRAPHIC (CT) SCAN EXCLUSION CRITERIA
|
|||
Sex/Gender |
|
|||
Ages | 18 Years to 80 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Italy | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00640367 | |||
Other Study ID Numbers ICMJE | SYNTHESIS EXPANSION | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Niguarda Hospital | |||
Study Sponsor ICMJE | Niguarda Hospital | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Niguarda Hospital | |||
Verification Date | April 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |