Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management, EAST-BP
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- The proportion of symptomatic intracranial hemorrhage
研究概览
简要总结
This study is a Phase II, exploratory, prospective, multicenter, open-label, randomized controlled clinical trial with blinded endpoint assessment setting on the safety of an adjusted versus a conventional blood pressure management strategy during intravenous thrombolysis in AIS patients, with a key focus on the incidence of symptomatic intracranial hemorrhage (sICH).
详细描述
This study is a Phase II, exploratory, prospective, multicenter, open-label, randomized controlled clinical trial with blinded endpoint assessment. EAST-BP aims to investigate the safety of an adjusted versus a conventional blood pressure management strategy during intravenous thrombolysis in AIS patients, according to an ordinal analysis of Proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis, proportion of severe or life-threatening major hemorrhage, DNT time for intravenous thrombolysis patients, proportion of independent functional prognosis at 90 days (90-day mRS 0-2), sequential analysis of improved 90-day mRS score for patients, proportion of death at 90 days, and neurological function status at 7 days or at discharge (if hospital stay is less than 7 days) .
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessor is independent of the treatment team
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 (inclusive);
- •Patients with acute ischemic stroke;
- •Planned to receive intravenous thrombolysis within 4.5 hours of onset;
- •Elevated blood pressure: Before receiving intravenous thrombolysis treatment, blood pressure is elevated: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg (defined as two consecutive measurements within 2 minutes);
- •Informed consent signed (or signed by a proxy).
排除标准
- •Intracranial hemorrhage is indicated on CT or MRI (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural or epidural hematoma).
- •History of intracranial hemorrhage; severe head trauma or stroke within the last 3 months.
- •Intracranial tumors, giant intracranial aneurysms.
- •Intracranial or spinal surgery within the last 3 months; major surgery within the last 2 weeks; arterial puncture at a site not easily compressed for hemostasis within the last 7 days.
- •Gastrointestinal or urinary system bleeding within the last 3 weeks.
- •Aortic dissection.
- •Acute bleeding tendency, including platelet count < 100×10^9/L or other bleeding tendencies.
- •Received low-molecular-weight heparin orally within 24 hours; taking warfarin with INR > 1.7 or PT > 15 seconds; used a new oral anticoagulant within 48 hours.
- •Blood glucose < 2.8 mmol/L or > 22.2 mmol/L.
- •Large area cerebral infarction indicated on head CT or MRI (infarction area > 1/3 of the middle cerebral artery territory).
- •Active visceral hemorrhage, known bleeding diathesis or significant bleeding disorders within the past 6 months
- •Severe ischemic stroke (NIHSS score > 25)
- •Epileptic seizures at the time of stroke onset
- •Pregnant or lactating women
- •Various terminal diseases with an expected survival of ≤ 3 months
- •Any other physical conditions where the doctor deems participation in this study may be detrimental to the patient
- •Currently participating in other drug or device clinical trials
- •mRS score > 2 before onset of the disease.
结局指标
主要结局
The proportion of symptomatic intracranial hemorrhage
时间窗: Day 1
The proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis according to ECASS III criteria
次要结局
- The proportion of intracranial hemorrhage transformation(Day 1)
- The proportion of major substantive hemorrhage(The proportion of major substantive hemorrhage occurring within 24 hours after thrombolysis (PH2))
- The proportion of severe or life-threatening major hemorrhage(DAY 90)
- time to use of reperfusion treatment(DAY 1)
- The proportion of symptomatic intracranial hemorrhage within 24 hours(DAY 1)
- level of physical function(DAY 90)
- death or dependency measured by a shift in mRS(DAY 90)
- Death(DAY 90)
- Neurological function measured by NIHSS(day 7 or at discharge)
- Neurological function measured by mRS(DAY 7 or at discharge)
- number of patients with serious adverse events(DAY 90)