Local Versus Systemic Thrombolysis for Acute Ischemic Stroke (SYNTHESIS)

Completed

Phase 3 Results

Update History

27 Oct '12
A location was updated in Milan.
New
The overall status was removed for AO Ospedale Niguarda Ca' Granda.
23 Feb '12
A location was updated in Milan.
New
The overall status was removed for AO Ospedale Niguarda Ca' Granda.
6 Oct '11
The eligibility criteria were updated.
New
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
Old
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