NanO2 in Large VessEL Occlusion Stroke (NOVEL): a Multicentre Single-blind, Randomised, Placebo-controlled Blinded Biomarker End-point Clinical Trial of Perfluorocarbon in Acute Ischaemic Stroke Due to Large Vessel Occlusion
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Volume of penumbral tissue salvaged based on follow-up imaging (diffusion weighted MRI, or non-contrast CT if MRI cannot be obtained) compared with pre-treatment penumbral tissue volume from CT Perfusion.
研究概览
简要总结
This is a National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) clinical trial aiming to investigate a possible new treatment to limit damage to the brain caused by a stroke. Strokes that are caused by a clot blocking an artery in the brain ('ischaemic' strokes) starve brain tissue of oxygen and nutrients. Over a short period of time without oxygen, this tissue becomes permanently damaged. The trial aims to investigate the effects of a drug that carries extra oxygen, called NanO2, on the amount of brain tissue damage. By carrying extra oxygen to brain tissue NanO2 may allow the tissue to survive for longer. It might be especially useful to prevent further damage happening while treatments to try and open the blocked blood vessel are given. Treatments may include 'clot-busting' drugs, or procedures to physically open a blocked artery. These treatments are very effective, but take time to successfully open the blockage. The study will involve treating people as early as possible after the stroke, and comparing brain scans before and after treatment. Patients diagnosed with a stroke that has occurred within the past 9 hours will be eligible to participate. The study will involve 8-15 hospitals across the UK. Participation in the study will last approximately 90 days. The majority of the study assessments will be during the first 5 days during inpatient hospital stay. There will be a telephone follow-up at 30 days and 90 days post-discharge.
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, Outcomes Assessor)
盲法说明
Statisticians
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
- •Male or non-pregnant female aged ≥ 18 years
- •Acute ischemic stroke fulfilling perfusion imaging criteria (ischemic core volume < 70 mL, mismatch ratio > 1.8 and mismatch volume > 15 mL using RAPID or equivalent CE-marked software)
- •Eligible for thrombolysis or thrombectomy
- •Intracranial LVO on CTA (occlusion of the terminal ICA, MCA-M1, ≥1 proximal MCA-M2, or proximal posterior cerebral artery (PCA-P1))
- •≤ 9 hours after last known well (if waking with symptoms, last known well time is calculated as the mid-point between going to sleep and waking)
- •Pre-stroke functional independence (estimated pre-stroke mRS ≤2)
- •NIHSS score ≥ 6 (or NIHSS ≥ 2 if PCA-P1 occlusion) at randomisation
排除标准
- •History of significantly impaired renal eGFR (<30ml/min) or hepatic function (transaminases >3 times upper limit of normal or history of cirrhosis), unstable angina or heart failure (NYHA 3 or 4).
- •Pre-existing lung disease requiring supplemental chronic or intermittent oxygen therapy (NB oxygen therapy given post-stroke is not an exclusion)
- •Previous hypersensitivity reaction to NanO2 excipients and/or compounds similar to NanO2
- •Pregnancy (for women of child-bearing potential a negative pregnancy test will be required prior to randomisation) or breast feeding women.
- •Women of child-bearing potential is defined as experienced menarche; AND not undergone successful surgical sterilisation (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy); AND not post-menopausal i.e. amenorrhea for ≥12 consecutive months (without another medical cause)
- •Participation in another CTIMP within preceding 90 days or 5 half-lives of the investigational product, whichever is longer, or previous participation in NOVEL.
研究组 & 干预措施
NanO2
干预措施: NanO2TM (Drug)
Placebo
干预措施: Sodium Chloride 0.9% Intravenous (Other)
结局指标
主要结局
Volume of penumbral tissue salvaged based on follow-up imaging (diffusion weighted MRI, or non-contrast CT if MRI cannot be obtained) compared with pre-treatment penumbral tissue volume from CT Perfusion.
时间窗: Baseline to 24hrs
次要结局
- National Institutes of Health Stroke Scale (NIHSS) change from baseline to day 5(Baseline to Day 5)
- NIHSS score change from baseline to 24h(Baseline to 24hrs)
- 24 hour NIHSS score(Baseline to 24hrs)
- Proportion achieving substantial early neurological improvement (NIHSS score reduced by ≥8 points or a score equal to 0 or 1) at 24 hours(Baseline to 24hrs)
- Distribution of modified Rankin Scale (mRS) scores at 30 and 90 days(Baseline to Day 30 and Day 90)
- Proportion achieving independence (mRS score ≤2) at 90 days(Baseline to Day 90)
- Proportion achieving excellent neurological outcome (mRS score 0-1) at 90 days(Baseline to Day 90)
- Health-related Quality of Life using the EQ-5D score at 90 days(Baseline to Day 90)
- Mortality(Baseline to Day 90)
- Cumulative incidence of Serious Adverse Events at 24h, day 5 and day 90(Baseline to Day 90)