RESCUE: A Randomized, Blinded, Placebo-controlled, Parallel Group Design to Determine the Safety of RNS60 in Large Vessel Occlusion Stroke Patients Undergoing Endovascular Thrombectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 11
- 主要终点
- Number of Participants With Serious Adverse Events (SAEs)
研究概览
简要总结
A Phase II, randomized, blinded, placebo-controlled, parallel group study with patients experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization. Participants will be given a 48 h infusion of either 0.5 mL/kg/h RNS60 (up to a maximum of 65 mL/h), 1.0 mL/kg/h RNS60 (up to a maximum of 130 mL/h), or 1.0 mL/kg/h (up to a maximum of 130 mL/h) placebo (normal saline) starting within 30 minutes of consent after confirmation of candidacy for endovascular thrombectomy.
详细描述
This study is a Phase II, randomized, blinded, placebo-controlled, parallel group design. Participants experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization will be given a 48 h infusion of either 0.5 mL/kg/h RNS60 (up to a maximum of 65 mL/h), 1.0 mL/kg/h RNS60 (up to a maximum of 130 mL/h), or 1.0 mL/kg/h (up to a maximum of 130 mL/h) placebo (normal saline) starting within 30 minutes of consent after confirmation of candidacy for endovascular thrombectomy and prior to arterial closure. Outcomes of the main trial will be evaluated throughout a 90 day observation period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke (AIS) selected for emergency endovascular treatment.
- •Age 18 years or older.
- •Onset (last-known-well) time to randomization time within 24 hours.
- •Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS)
- •NIHSS > 5 for internal carotid artery (ICA) and M1-middle cerebral artery (MCA) occlusion or
- •NIHSS > 10 for M2-MCA occlusion.
- •Confirmed symptomatic intracranial occlusion at one or more of the following locations: Intracranial carotid I/T/L, M1 or M2 segment MCA. Tandem extracranial carotid and intracranial occlusions are permitted.
- •Pre-stroke (24 hours prior to stroke onset) historical modified Rankin Scale (mRS) ≤
- •Patient must be living independently without requiring nursing care.
- •Qualifying imaging performed less than 2 hours prior to randomization.
- •Consent process completed as per applicable laws and regulation and the IRB requirements.
排除标准
- •Evidence of a large core of established infarction defined as Alberta Stroke Program Early Computerized Tomography Score (ASPECTS) 0-
- •Evidence of absence of collateral circulation on qualifying imaging (collateral score of 0 or 1 if multiphase computed tomography angiography (mCTA) is used, or absence of adequate ischemic penumbra in the judgment of the Investigator if computed tomographic perfusion (CTP) is used).
- •Any evidence of intracranial hemorrhage or mass lesion on the qualifying imaging.
- •Planned use of an endovascular device not having approval or clearance by the relevant regulatory authority.
- •Endovascular thrombectomy procedure is completed as defined by the presence of arterial access closure.
- •Clinical history, past imaging or clinical judgment suggesting that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.
- •Estimated or known weight > 130 kg (287 lbs).
- •Known pregnant/lactating female.
- •Myocardial infarction (MI) within 6 months prior to Screening including non-Q wave MI; Diagnosis of congestive heart failure (CHF) with either:
- •current clinical signs and symptoms of ventricular dysfunction (e.g., edema, shortness of breath),
- •CHF medication adjustment within the prior 30 days or
- •ejection fraction (if report available) of 30% or less measured in the 6 months prior to Screening; as either medically documented or reported by patient or another person considered by the Investigator to be reasonably reliable.
- •Known renal impairment defined as requiring renal replacement therapy (hemo- or peritoneal dialysis).
- •Inability to have magnetic resonance imaging (MRI) (Non-magnetic resonance [MR] compatible implants or any other foreseeable reason, including claustrophobia)
- •Severe or fatal comorbid illness that will prevent improvement or follow up.
- •Inability to complete follow-up treatment to Day
- •Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion and throughout the duration of the trial.
- •Reported known seizure at time of stroke onset.
- •Ischemic stroke within previous 30 days.
- •Patients in normal sinus rhythm with a known QTcF > 460 ms at Screening.
- •Any other symptom that in the investigator's opinion may complicate or preclude the subject from participating in this trial.
研究组 & 干预措施
RNS60 0.5 mL/kg/h
RNS60 0.5 mL/kg/h infusion for 48h (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure)
干预措施: RNS60 (Drug)
RNS60 1.0 mL/kg/h
RNS60 1.0 mL/kg/h infusion for 48h (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure)
干预措施: RNS60 (Drug)
Placebo 1.0 mL/kg/h
Placebo (normal saline) 1.0 mL/kg/h infusion for 48h (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure)
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Serious Adverse Events (SAEs)
时间窗: From start of study drug administration up to Day 90
An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in a congenital anomaly/birth defect. An SAE could also be an important medical event that may not have resulted in death, was life-threatening, or required hospitalization, but jeopardized the participant and required medical or surgical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs were defined as SAEs that started after the start of study drug infusion and are reported here.
Mortality: Proportion of Participants Alive at Day 90
时间窗: Day 90
次要结局
- Percentage of Participants With Barthel Index (BI) Score ≥95 at Day 90(Day 90)
- Number of Participants With Non-disability Based on Modified Rankin Scale (mRS ) Score at Day 90(Day 90)
- Change From Baseline in Infarct Volume of Stroke at 48 Hours(Baseline, 48 hours)
- National Institutes of Health Stroke Scale (NIHSS) at 24 Hours(24 hours)
- Proportion of Participants With Worsening of Stroke(Up to Day 90)
- Health-related Quality of Life as Measured by 5-Level EuroQoL 5D Index (EQ-5D-5L) at Day 90(Day 90)