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


Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

For patients within 3 hrs time-windows, the only inclusion criterion for rt-PA (IV) thrombolysis is to satisfy the product instruction of rt-PA. The following are the inclusion criteria for patients within 3-9 hrs time-windows: 1. Female or male inpatients 2. Age 18-80 years 3. Clinical diagnosis of ischaemic stroke 4. Onset of symptoms within 3-9 hours prior to initiation of thrombolysis treatment 5. Stroke symptoms present for at least 30 minutes and has not significantly improved before treatment 6. The National Institute of Health Stroke Scale (NIHSS) score of greater or equal to 4 7. m-CT screening to be started within 8.5 hrs after stroke onset 8. Perfusion abnormality of CT scan >2cm in diameter involving hemisphere 9. CT perfusion/CTA source image mismatch greater than or equal to 20% 10. CTA shows occlusion or significant stenosis of large vessels (Thrombolysis in Cerebral Ischemia [TICI] grade is 0 or 1) 11. Patients are willing to receive thrombolysis treatment and to give informed consent 12. Patients are willing and able to comply with the study protocol

Exclusion Criteria

For patients within 3 hrs time-windows, the only exclusion criterion for rt-PA (IV) thrombolysis is to satisfy the product instruction of rt-PA. The following are the exclusion criteria for patients within 3-9 hrs time-windows: 1. Evidence of IntraCranial Haemorrhage (ICH), brain tumors, vascular malformation, aneurysm, SubArachnoid Hemorrhage (SAH) 2. Major infarct involving >1/3 of MCA territory on the CTA-SI 3. Presenting obvious neurologic deficits because of past stroke (modified Rankin Scale [mRS] >2) 4. Severe stroke as assessed clinically (e.g. NIHSS >25) and/or by appropriate, magnetic imaging techniques 5. Seizure at onset of stroke 6. Prior stroke within the last 3 months 7. Patients with any history of prior stroke and concomitant diabetes 8. Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory 9. Platelet count of below 100,000/mm3. 10. 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 11. Blood glucose <50 or >400 mg/dl 12. Known haemorrhagic diathesis within the last 6 months 13. Patients receiving oral anticoagulants, e.g. warfarin sodium, and coagulant response time (INR) >1.5 14. Known history of or suspected intracranial haemorrhage including subarachnoid haemorrhage 15. Pregnancy or lactation 16. Any history of severe central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) 17. Haemorrhagic retinopathy,e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy) 18. Bacterial endocarditis, pericarditis 19. 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) 20. Acute pancreatitis 21. Documented ulcerative gastrointestinal disease during the last 3 months 22. Oesophageal varices, arterial aneurysm, arterial/venous malformation 23. Neoplasm with increased bleeding risk 24. Severe liver disease, including hepatic failure, cirrhosis, portal hypertension, oesophageal varices and active hepatitis 25. Major surgery or significant trauma in past 10 days 26. Known serious sensitivity to alteplase