Health Condition 1: I633- Cerebral infarction due to thrombosis of cerebral arteries
Conditions
Interventions
Intervention1: N Acety Cysteine: N Acety Cysteine 150mg/Kg Intravenous over 60minutes along with tissue plasminogen activator tPA (alteplase) in intervention arm and tPA alone in control arm.
Control
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients presenting with anterior circulation acute ischemic stroke within 4.5 hours of stroke onset. 2.Age is >=18 years and upto 80 years. 3.Eligible using standard criteria to receive intravenous (IV) thrombolysis with alteplase ( tissue plasminogen activator) 4.Patient, family member or legally responsible person depending on local ethics requirements has given informed consent 5.Where indicated, endovascular thrombectomy can commence (groin puncture) within 6 hours of stroke onset and in highly selected cases up to 24hours based on imaging inclusion criteria. 6.Patients with ASPECTS score > or equal to 7.
Exclusion criteria
Exclusion criteria: 1. Intracranial hemorrhage (ICH) identified by CT or MRI 2. Pre-stroke mRS score of >= 2 (indicating previous disability) 3. Hypodensity in >1/3 MCA territory on non-contrast CT 4. Angiographic evidence of carotid dissection 5. Contra indication to imaging with contrast agents 6. Any terminal illness such that the patient would not be expected to survive long. 7. Pregnant women 8. Previous stroke within last three months 9. Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm (at the discretion of investigator) 10. Current use of oral anticoagulants and a prolonged prothrombin time (INR > 1.7) 11. Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours and a prolonged activated partial thromboplastin time exceeding the upper limit of the local laboratory normal range. 12. Use of glycoprotein IIb-IIIa inhibitors within the past 72 hours. Prior use of single or dual agent oral platelet inhibitors (clopidogrel and/or low-dose aspirin) permitted 13. Clinically significant hypoglycaemia 14. Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or >110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart 15. Hereditary or acquired hemorrhagic diathesis 16. Gastrointestinal or urinary bleeding within the preceding 21 days 17. Major surgery within the preceding 14 days which posed risk 18. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Outcome : 1.Any adverse reactions of IV administration of N Acetyl cysteine: Mild symptoms like nausea, vomiting, flushing, rash, pruritis, headache, dizziness and serious adverse events like bronchospasm and hypotension. 2.Any symptomatic cerebral hemorrhage /Haemorrhagic transformation (haemorrhagic infarct / haematoma) as defined by CT (or MRI) occurring within 72 hours as per SITS criteria 3.Any major or minor systemic bleeding Timepoint: 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Major neurologic improvement at 24 hours (defined as a reduction from baseline of 8 or more points on the NIHSS. 2.Recanalisation at angiography among patients underging thrombectomy/ thromboaspiration or both or at 24 hours after the stroke. 3.Morbidity as assessed by mRS at 90days. An mRS 2will be taken as a good outcome. 4.Mortality at 90 days Timepoint: 24hours,72hours,3months | — |
Countries
India
Contacts
Public ContactDrRohit Bhatia
AIIMS, New Delhi
Outcome results
None listed