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)