Low-dose Versus Standard-dose Ateplase in Acute Ischemic Stroke ; A 4 Months Prospective Randomized Control Pilot Follow by Single Arm Standard Dose Ateplase Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- Death in 3 months
研究概览
简要总结
Cohort A Randomized Control trial of Ateplase 0.6, 0.75 and 0.9 mg/kg in 78 patients Cohort B single arm 0.9 mg/kg Ateplase in 330 patients Combined Cohort A and B evaluate different of death, intra-cerebral hemorrhage, numberof patient with mRS 0-1 at discharge and 3 months follow up, and other important stroke outcomes
详细描述
We conducted the prospective study to compare the low-dose and standard-dose rtPa and identify the important factors predicted stroke outcomes in acute stroke patient received intravenous rtPa. In Cohort A, During 2011-2012, 78 patients were randomly assigned to received intravenous rtPa 0.6 mg/kg , 0.75 mg/Kg, or 0.9 mg/Kg (1:1:1). After interim analysis during 2012-2017, in Cohort B, 330 patients were assigned to receive standard-dose rtPa 0.9 mg/kg. The good outcomes were defined as improvement of modified Rankin scale (mRS) by final score 0-1 or improvement > 4 points at discharge or 3 months follow up, absent of intracranial hemorrhage within 36 hours treatment, 90-day post-stroke survival , and short hospital length of stay.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Diagnosis of Acute ischemic stroke
- •Age 18 to 80 years
- •Onset of stroke symptoms with in 4.5 hours before initiation of study-drug administration
- •Stroke symptoms present for at least 30 minutes with no significant improvement before treatment
排除标准
- •patients with Intracranial hemorrhage
- •the symptoms of Time onset was unknown
- •Symptoms rapidly improving or only minor before start of infusion
- •Seizure at the onset of stroke
- •Stroke or serious head trauma within the previous 3 months
- •Administration of heparin within the 48 hours preceding the onset of stroke, with an activate
- •partial-thromboplastin time at presentation exceeding the upper limit of the normal range
- •Platelet count of less than 100,000 per cubic millimeter
- •Systole pressure greater than 185 mm Hg or diastole pressure greater than 110 mm Hg, or aggressive treatment intravenous medication) necessary to reduce blood pressure to these limits
- •Blood glucose less than 50 mg per deciliter or greater than 400 mg per deciliter
- •Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
- •Oral anticoagulant treatment
- •Major surgery or severe trauma within the previous 3 months
- •Other major disorders associated with an increased risk of bleeding
研究组 & 干预措施
0.6 mg/kg Ateplase
Low dose 0.6 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke (n = 26 in cohort A)
干预措施: Intravenous Solution Ateplase (Drug)
0.75 mg/kg Ateplase
Low dose 0.75 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke(n = 26 in cohort A)
干预措施: Intravenous Solution Ateplase (Drug)
0.9 mg/kg Ateplase
Low dose 0.9 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke(n = 26 in cohort A and n= 330 in Cohort B)
干预措施: Intravenous Solution Ateplase (Drug)
结局指标
主要结局
Death in 3 months
时间窗: 0-3 months
Number of patient die in 3 months
Total number of patients with mRS 0-1 at discharged
时间窗: 1day to <3 months
Number of patients with mRS 0-1 at discharge 1day to 3 months interval
Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 36 hours
时间窗: 0-36 hours
Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration
Total number of patients with mRS 0-1 at 3 months
时间窗: At 3 months
Number of patients with mRS 0-1 at 3 months
Number of patients with All intra-cerebral hemorrhage (ICH) at 36 hours
时间窗: 0- 36 hours
Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH
Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 36 hours
时间窗: 0-36 hours
Total Number of patients with Symptomatic ICH need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration
Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 4 months
时间窗: 0-4 months
Total Number of patients with Symptomatic ICH need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration
Death in 36 hours
时间窗: 0-36 hours
Number of patient die in 36 hours
Death in 4 months
时间窗: 0-4 months
Number of patient die in 4 months
Number of patients with All intra-cerebral hemorrhage (ICH) at 3 months
时间窗: 0-3 months
Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH
Number of patients with All Intra-cerebral hemorrhage (ICH) at 4months
时间窗: 0-4 months
Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH
Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 3 months
时间窗: 0-3 months
Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration
Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 4 months
时间窗: 0-4 months
Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration
次要结局
- Improved mRS 3 months(At 3 months)
- Improved mRS at discharge((At discharge) 1 day to 3 months)
- Good stroke outcomes(0-4 months)
- Number of patienta with Length of hospital stay (LOS) less than 7 days Days(1- 7 days)
- All complications(0-4 months)
研究者
Dr Subsai Kongsaengdao
Associated Professor
Rajavithi Hospital