Status:
COMPLETED
Intra-arterial Versus Systemic Thrombolysis for Acute Ischemic Stroke
Lead Sponsor:
Niguarda Hospital
Conditions:
Stroke
Cerebrovascular Accident
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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-plasmin...
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 ...
Eligibility Criteria
Inclusion
- Sudden focal neurological deficit attributable to a stroke
- Clearly defined time of onset, allowing initiation of intravenous treatment within 3 hours of symptoms onset and intra-arterial treatment within 6 hour of symptoms onset.
- Age greater than 18 years
Exclusion
- Disability preceding stroke consistent with a modified Rankin scale score of 2-4
- Coma at onset
- Rapidly improving neurological deficit
- Seizure at onset
- Clinical presentation suggestive of a subarachnoid hemorrhage
- Previous history of intracranial hemorrhage
- Septic embolism
- Arterial puncture at a non compressible site within the previous 7 days
- Any traumatic brain injury within the previous 14 days
- Surgery of the central nervous system in the previous 3 months
- Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 14 days.
- Current therapy with intravenous or subcutaneous heparin to rise the clotting time
- Known hereditary or acquired hemorrhagic diathesis, baseline INR greater than 1.5, aPTT more than 1.5 times normal, or baseline platelet count less than 100,000 per cubic millimeter
- Baseline blood glucose concentrations below 2.75 mm/L (50 mg/dL).
- Known contrast sensitivity.
- Women of childbearing potential (unless pregnancy impossible) or known to be breastfeeding. Uncontrolled hypertension defined by a blood pressure greater or equal 185 mmHg systolic or diastolic greater or equal 110 mm Hg in 3 separate occasions at least 10 minutes apart or requiring continuous IV therapy.
- Prognosis very poor regardless of therapy; likely to be dead within months.
- Unlikely to be available for follow-up (eg, no fixed home address, visitor from overseas).
- Any other condition which local investigators feels would pose a significant hazard in terms of risk/benefit to the patient, or if therapies are impracticable.
- COMPUTED TOMOGRAPHIC (CT) SCAN EXCLUSION CRITERIA
- Intracranial tumors except small meningioma
- Hemorrhage of any degree
- Acute infarction (since this may be an indicator that the time of onset is uncorrected)
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00640367
Start Date
February 1 2008
End Date
July 1 2012
Last Update
April 25 2014
Active Locations (1)
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1
A.O. Ospedale Ca' Granda
Milan, Milan, Italy, 20162