Clinical diagnosis of ischaemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition, gaze, vision and/or neglect. Ischaemic stroke is defined as an event characterised by sudden onset of acute focal neurological deficit, presumed to be caused by cerebral ischaemia, after CT scan exclusion of haemorrhage; onset of symptoms within 4.5 hours prior to initiation of thrombolysis treatment; stroke symptoms present for at least 30 minutes and has not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischaemia (i.e. syncope), seizure, or migraine disorder; patients are willing to receive thrombolysis treatment and to give informed consent with regard to retrieval of data and follow up procedures, according to the regulations in participating countries.
Evidence of intracranial haemorrhage (ICH) on the CT-scan.Symptoms of ischaemic attack began more than 4.5 hours prior to infusion start or when time of symptom onset is unknown; minor neurological deficit or symptoms rapidly improving before start of infusion; severe stroke as assessed clinically (e.g. NIHSS>25) and/or by appropriate imaging techniques; seizure at onset of stroke; symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is normal;administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory; patients with any history of prior stroke and concomitant diabetes; prior stroke within the last 3 months; platelet count of below 100,000/mm3; systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, or aggressive management (IV medication) necessary to reduce BP to these limits; blood glucose <50 or > 400 mg/dl; known haemorrhagic diathesis; patients receiving oral anticoagulants, e.g. warfarin sodium; manifest or recent severe or dangerous bleeding; known history of or suspected intracranial haemorrhage; suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from aneurysm;any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery); haemorrhagic retinopathy,e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy); recent (less than 10 days) traumatic external heart massage, obstetrical delivery,recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture; bacterial endocarditis, pericarditis; acute pancreatitis; documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial- aneurysm, arterial/venous malformation; neoplasm with increased bleeding risk; severe liver disease, including hepatic failure, cirrhosis, portal hypertension, esophageal varices and active hepatitis;major surgery or significant trauma in past 3 months.