A clinical trial to study safety and efficacy of N-Acetylcysteine (NAC)(new drug) as an adjunct to standard treatment in patients with acute ischemic stroke

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Outcome : <br/ ><br>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. <br/ ><br>2.Any symptomatic cerebral hemorrhage /Haemorrhagic transformation (haemorrhagic infarct / haematoma) as defined by CT (or MRI) occurring within 72 hours as per SITS criteria <br/ ><br>3.Any major or minor systemic bleeding <br/ ><br>Timepoint: 72 hours

Secondary Outcome Measures

Name	Time	Method
1.Major neurologic improvement at 24 hours (defined as a reduction from baseline of 8 or more points on the NIHSS. <br/ ><br>2.Recanalisation at angiography among patients underging thrombectomy/ thromboaspiration or both or at 24 hours after the stroke. <br/ ><br>3.Morbidity as assessed by mRS at 90days. An mRS 2will be taken as a good outcome. <br/ ><br>4.Mortality at 90 days <br/ ><br> <br/ ><br>Timepoint: 24hours,72hours,3months