TENECTEPLASE VERSUS ALTEPLASE FOR THROMBOLYSIS IN ACUTE ISCHEMIC STROKE- AN OPEN LABEL RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Improvement in NIHSS at 24 hours and at 72 hours post thrombolysis
研究概览
简要总结
This open label, randomized controlled trial of tenecteplase versus alteplase for thrombolysis in acute ischemic stroke assesses the efficacy and safety of tenecteplase versus alteplase as thrombolytic agents in acute ischemic stroke patients within 4.5 hours of symptom onset. As soon as suspected stroke patient visit AIIMS Jodhpur, imaging is done. Eligible patients, who follows the inclusion criteria and after ruling out the exclusion criterias, undergo randomisation for either tenecteplase or alteplase administration by block randomisation method. After taking Written informed consent from the patient family members, patient will be thrombolysed with either tenecteplase (bolus 0.25 mg per kg ,maximum 25 mg ) or alteplase (0.9 mg/kg maximum 90 mg, with 10 percent of total dose as bolus and remaining dose as infusion over 1 hour ) as per randomisation group. This is followed by repeat imaging after 24 hours and neurological assessment will be done to compare outcomes including NIHSS, mRS and other safety outcomes. Adverse effects will be managed. patient will be assessed in follow up for NIHSS and mRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •age more than or equal to 18 years, patients with acute ischemic stroke, onset of symptoms less than 4.5 hours, if exact time of stroke is unknown,it is defined as the last time the patient was known to be normal or at neurologic baseline.
- •Wake up stroke-patients with acute ischemic stroke who wake up with stroke symptoms or have unclear time of onset more than 4.5 hours from last known wellor at baseline state and who have a DW-MRI lesionsmaller than one third of the MCA territory and no visible signal change on FLAIR .
- •Diffusion FLAIR mismatch.
- •Informed and signed consent.
排除标准
- •Ischemic stroke or severe head trauma in previous three months, previous intracranial haemorrhage, patient with intracerebral haemorrhage in NCCT head, persistent blood pressure elevation( SBP more than or equal to 185 mm hg or DBP more than or equal to 110 mm hg), intra-axial intracranial neoplasm, Gastrointestinal malignancy, Gastrointestinal haemorrhage in previous 21 days, Infective endocarditis, Aortic arch dissection, Acute head trauma, Subarachnoid haemorrhage, Minor non disabiling stroke, Intracranial or intraspinal surgery within prior 3 months, major surgery in preceeding 14 days, recent history of ICH, subarachnoid haemorrhage, AVM, aneurysm or cerebral neoplasm, Arterial puncture at non compressible site in previous 7 days, acute bleeding diasthesis, platelet count less than 1 lakh/mm3, pregnant female, non availability of inr if patient is on vka, current anticoagulant use with inr more than 1.7 or pt more than 15 seconds or aptt more than 40 seconds, therapeutic doses of low molecular heparin received within 24 hours example to treat vte and acs, this exclusion doesnot apply to prophylactic dose,example to prevent VTE, Use of glycoprotein IIbIIIa inhibitors within past 72 hours, patient of acute ischemic stroke who are thrombolysed outside the study centre, Current use (that is last dose within 48 hours in a patient with normal renal function) of a direct thrombin inhibitor or direct factor Xa inhibitor with evidence of anticoagulant effect by laboratory tests such as APTT,INR,ECT,TT or appropriate factor Xa activity assays, patient who gave negative consent for intravenous thrombolysis.
结局指标
主要结局
Improvement in NIHSS at 24 hours and at 72 hours post thrombolysis
时间窗: 24 hours and 72 hours
次要结局
- 1.mRS at 1 month and at 3 months(2.Radiological evolution on the basis of NCCT head and CTA)
研究者
Dr Dolly Agrawal
AIIMS JODHPUR