CTRI/2019/05/019305尚未招募2 期
Safety and efficacy of N-Acetylcysteine (NAC) as an adjunct to standard treatment in patients with acute ischemic stroke â?? A Phase II Randomized Controlled Trial
AIIMS New Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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
研究者
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