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| Sponsor: | Niguarda Hospital |
|---|---|
| Information provided by: | Niguarda Hospital |
| ClinicalTrials.gov Identifier: | NCT00540527 |
Purpose
The purpose of this study is to determine whether intra-arterial rt-PA within 6 hours from an ischemic stroke onset, compared with intravenous infusion of the same drug within 3 hours, increases the proportion of independent survivors at 3 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke Cerebrovascular Accident |
Drug: cal intraarterial recombinant tissue plasminogen activator Drug: intravenous (IV) rt-PA |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | SYNTHESIS: a Randomized Controlled Trial on Intra-arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke. Start up Phase. |
| Estimated Enrollment: | 350 |
| Study Start Date: | January 2004 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
local intraarterial recombinant tissue plasminogen activator
|
Drug: cal intraarterial recombinant tissue plasminogen activator |
|
2: Active Comparator
intravenous (IV) rt-PA
|
Drug: intravenous (IV) rt-PA |
"Stroke is a major cause of death and severe disability.The only effective, available therapy, within few hours of stroke onset, is rt-PA, a thrombolytic agent. Preliminary experience but not from properly conducted randomized trials indicates that intra-arterial treatment might be more effective than intravenous therapy for some vascular lesions. Intravenous application has not been tested directly against intra-arterial treatment and we do not known the relative clinical effectiveness with these two routes of administration. Eligible patients will be randomized to receive either IV rt-PA (0.9mg/kg; max 90 mg), 10% of which would be infused over 1 minute, and the remainder over 60 min, or IA rt-PA within the thrombus by means of microcatheter. In patients allocated to IA rt-PA the angiogram is performed as soon as possible within 6 hours of stroke onset; IV heparin has to be initiated (2000 U bolus followed by 500 U7hr infusion) and rt-PA is delivered at a rate of about 90 mg/hr for maximum one hour at the dose needed for recanalization up to 0.9 mg/Kg (max 90 mg). Antithrombotics and anticoagulants are disallowed during the first 24 hours (except heparin used during the angiogram). After 24 hrs, all patients will be considered for long-term antiplatelet or anticoagulant therapy. Follow-up will take place at 7 days, discharge, or transfer, whichever is first; and again at 3 months. 4 centers are currently authorized for the start-up phase; 15 centers in Italy have applied for an expansion phase of the study (SYNTHESIS EXPANSION), with financial support from Italian National Agency for Drugs (AIFA).The two phases of the study will be analysed separately and will be considered in a pooled analysis.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Computed tomographic (CT) scan exclusion criteria
Contacts and Locations
More Information
| Responsible Party: | AO Ospedale Niguarda Ca' Granda ( AO Ospedale Niguarda Ca' Granda ) |
| Study ID Numbers: | SYNTHESIS |
| Study First Received: | October 5, 2007 |
| Last Updated: | July 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00540527 History of Changes |
| Health Authority: | Italy: Ministry of Health |
|
acute ischemic stroke;thrombolysis;intraarterial thrombolysis |
|
Molecular Mechanisms of Pharmacological Action Cerebral Infarction Hematologic Agents Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Tissue Plasminogen Activator Fibrinolytic Agents Cardiovascular Agents |
Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Fibrin Modulating Agents Therapeutic Uses Brain Ischemia Cardiovascular Diseases Brain Infarction Plasminogen |