Overview

Intra-arterial Versus Systemic Thrombolysis for Acute Ischemic Stroke

Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Niguarda Hospital
Treatments:
Plasminogen
Tissue Plasminogen Activator
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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)