Phase IIb Study Comparing Tenecteplase to Alteplase in Acute Ischemic Stroke Within 3 to 4.5 Hours From Symptom Onset
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Neurological outcome
研究概览
简要总结
This is a double-blind parallel arm randomized trial aimed to assess efficacy and safety of intravenous Tenecteplase compared to intravenous Alteplase in eligible patients who present with symptoms of acute ischemic stroke within 3 to 4.5 hours from onset.
详细描述
Patients presenting with symptoms of acute ischemic stroke (AIS) who present within 3 to 4.5 hours of symptom onset and who meet the inclusion criteria for intravenous (IV) thrombolysis will receive, in a randomized, double-blind fashion, either IV Alteplase at 0.9 mg/kg per standard protocol or IV Tenecteplase at 0.25 mg/kg with saline infusion over one hour. Patients must also have no exclusion criteria for IV thrombolysis within the 3 to 4.5 hour window. The only required imaging is non-contrasted CT of the head. Patients will be monitored according to standard post-thrombolytic care. A CT of the head will be performed at 24 hours based on standard protocol or if there is any neurological change. Neurological function at 24 hours using NIHSS and at 3 months based on modified mRS and the NIHSS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years
- •Acute neurologic deficit with an NIHSS ≥ 4
- •Non-enhanced computed tomography (NECT) of the head showing no hemorrhage
- •Acute ischemic stroke symptoms with onset, or time last known well, clearly defined between 3 and 4.5 hours
- •Treatment can be initiated within 3 to 4.5 hours from symptom onset
排除标准
- •Evidence of intracranial hemorrhage on NECT
- •Clinical suspicion of subarachnoid hemorrhage even with normal NECT
- •NECT shows hypo-density greater than 1/3 cerebral hemisphere)
- •History of intracranial hemorrhage/stroke
- •Uncontrolled HTN: At time treatment begins SBP remains >185 mmHg or DBP remains >110 mmHg despite repeated measurements
- •Known arteriovenous malformation, neoplasm, or aneurysm
- •Witnessed seizure at stroke onset
- •Acute bleeding tendencies
- •Platelet count <100,000/mm3
- •Heparin received in prior 48 hours with elevated aPTT
- •Current use of an anticoagulant (Coumadin/Warfarin) irrespective of INR
- •Prior use (within 48 hours) of direct thrombin inhibitors (dabigatran) or direct factor Xa inhibitors (rivaroxaban, apixaban)
- •Within prior 3 months: intracranial or spinal surgery, head trauma, or previous stroke
- •Arterial puncture at non-compressible site within last 7 days
- •Woman of child bearing age who has a positive pregnancy test
- •NIH stroke scale >25 (severe deficit) or <4 and no dysphasia (mild deficit) or rapidly improving
- •Symptoms spontaneously clearing
- •14 days post-operative or post major trauma
- •Recent gastrointestinal or urinary tract hemorrhage within the past 21 days
- •Recent acute MI within the past 3 months
- •Serum glucose <50 mg/dl or >400 mg/dL
- •Age >80 or less than 18
- •History of ischemic stroke AND diabetes mellitus
- •Unable to obtain consent from patient or power of attorney
- •Baseline mRS > 2
- •Consent not obtained by 20 minutes prior to closure of the therapeutic window.
- •The subject has been treated with a thrombolytic agent within the past 72 hours
- •The subject is a pregnant woman (positive serum βHCG pregnancy test, positive urine pregnancy test or clinically evident pregnancy)
- •The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason
研究组 & 干预措施
Tenecteplase
Tenecteplase 0.25 mg/kg IV - Maximum dose: 25 mg
干预措施: Tenecteplase (Drug)
Alteplase
Alteplase 0.9 mg/kg IV - Maximum dose: 90 mg
干预措施: Alteplase (Drug)
结局指标
主要结局
Neurological outcome
时间窗: 90 days
Measured by modified Rankin Scale score
次要结局
- Symptomatic intracranial hemorrhage(24 hours)
研究者
Reza Behrouz, DO
Associate Professor of Neurology
Ohio State University