Local Versus Systemic Thrombolysis for Acute Ischemic Stroke (SYNTHESIS)

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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 between 18 and 80 years

Exclusion criteria:

• Disability preceding stroke consistent with a modified Rankin scale score of 2-4 (see glossary for Rankin scale)

• Coma at onset

• Severe stroke as assessed clinically (e.g. NIHSS>25)

• Rapidly improving neurological deficit or minor symptoms

• Seizure at onset of stroke

• Clinical presentation suggestive of a subarachnoid hemorrhage (even of CT scan is normal) or condition after subarachnoid hemorrhage from aneurysm

• Previous history of or suspected intracranial hemorrhage

• Previous history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)

• Septic embolism, bacterial endocarditis, pericarditis

• Acute pancreatitis

• Arterial puncture at a non compressible site (e.g. subclavian or jugular vein puncture) or traumatic external heart massage or obstetrical delivery within the previous 10 days

• Another stroke or serious head trauma within the preceding 3 months

• Major surgery or significant trauma in past 3 month

• Urinary tract hemorrhage within the previous 21 days

• Documented ulcerative gastrointestinal disease during the last 3 months, esophageal varices, arterial-aneurysm, arterial/venous malformations • Neoplasm with increased bleeding risk

• Severe liver disease, including hepatic failure, cirrhosis, portal hypertension (esophageal varices) and active hepatitis

• Current therapy with intravenous or subcutaneous heparin or oral anticoagulants (e.g. warfarin sodium) 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 50 mg per deciliter (2.75 mm/L) or above 400 mg per deciliter

• Hemorrhagic retinopathy, e.g. in diabetes (vision disturbances may indicate hemorrhagic retinopathy)

• Any history of prior stroke and concomitant diabetes

• Prior stroke within the last 3 months

• Known contrast sensitivity

• Severe uncontrolled hypertension defined by a blood pressure ≥ 185 mmHg systolic or diastolic ≥ 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 (e.g., 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