Imaging-based Thrombolysis trial in Acute Ischemic Stroke -III "ITAIS- III "

Active, not recruiting

Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of ischaemic stroke; onset of symptoms within 3-9 hours prior to initiation of thrombolysis treatment; stroke symptoms present for at least 30 minutes and has not significantly improved before treatment; National Institutes of Health Stroke Scale (NIHSS) score greater than or equal to 4; m-CT screening to be started within 8.5 hrs after stroke onset; perfusion abnormality of CT scan >2cm in diameter involving hemisphere; CT Perfusion/CTA source image mismatch greater than or equal to 20%; CTA shows occlusion or significant stenosis of large vessels (Thrombolysis In Cerebral Ischemia [TICI] grade is 0 or 1); patients are willing and able to comply with the study protocol.

Exclusion Criteria

Evidence of IntraCranial Haemorrhage (ICH), brain tumors, vascular malformation, aneurysm, SubArachnoid Hemorrhage (SAH); major infarct involving greater than 1/3 of Middle Cerebral Artery (MCA) territory on the CTA-SI; presenting obvious neurologic deficits because of past stroke (mRS >2); severe stroke as assessed clinically (e.g. The National Institute of Health Stroke Scale [NIHSS] >25) and/or by appropriate magnetic imaging techniques; seizure at onset of stroke; prior stroke within the last 3 months; patients with any history of prior stroke and concomitant diabetes; administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory; platelet count of below 100,000/mm3; uncompensated hypertension at study entry or hypertension requiring aggressive treatment to reduce blood pressure to nonhypertensive limits. Uncompensated hypertension is defined as systolic blood pressure >185 mm Hg or diastolic blood pressure >=110 mm Hg on 3 repeated measures at least 10 minutes apart; blood glucose <50 or >400 mg/dl; known haemorrhagic diathesis within the last 6 months; patients receiving oral anticoagulants e.g. warfarin sodium, and coagulant response time (INR) >1.5; known history of or suspected intracranial haemorrhage including subarachnoid haemorrhage; pregnancy or lactation; any history of severe central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery); haemorrhagic retinopathy,e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy); bacterial endocarditis, pericarditis; prolonged traumatic external heart massage, or recent (less than 10 days) obstetrical delivery or recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture); acute pancreatitis; documented ulcerative gastrointestinal disease during the last 3 months;esophageal varices, arterial aneurysm, arterial/venous malformation; neoplasm with increased bleeding risk; severe liver disease including hepatic failure, cirrhosis, portal hypertension, oesophageal varices and active hepatitis; major surgery or significant trauma in past 10 days; known serious sensitivity to alteplase.