1 Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.
2 Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
Int J Stroke. 2019 Feb;14(2):191-206. doi: 10.1177/1747493017724627. Epub 2017 Aug 1.
Vascular nitric oxide levels are low in acute stroke and donors such as glyceryl trinitrate have shown promise when administered very early after stroke. Potential mechanisms of action include augmentation of cerebral reperfusion, thrombolysis and thrombectomy, lowering blood pressure, and cytoprotection.
To test the safety and efficacy of four days of transdermal glyceryl trinitrate (5 mg/day) versus sham in patients with ultra-acute presumed stroke who are recruited by paramedics prior to hospital presentation.
The sample size of 850 patients will allow a shift in the modified Rankin Scale with odds ratio 0.70 (glyceryl trinitrate versus sham, ordinal logistic regression) to be detected with 90% power at 5% significance (two-sided).
The Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) is a multicentre UK prospective randomized sham-controlled outcome-blinded parallel-group trial in 850 patients with ultra-acute (≤4 h of onset) FAST-positive presumed stroke and systolic blood pressure ≥120 mmHg who present to the ambulance service following a 999 emergency call. Data collection is performed via a secure internet site with real-time data validation.
The primary outcome is the modified Rankin Scale measured centrally by telephone at 90 days and masked to treatment. Secondary outcomes include: blood pressure, impairment, recurrence, dysphagia, neuroimaging markers of the acute lesion including vessel patency, discharge disposition, length of stay, death, cognition, quality of life, and mood. Neuroimaging and serious adverse events are adjudicated blinded to treatment.
RIGHT-2 has recruited more than 500 participants from seven UK ambulance services.
Trial is ongoing.
British Heart Foundation.
ISRCTN26986053.
急性脑卒中患者的血管一氧化氮水平较低，甘油三硝酸酯等供体在脑卒中后早期给予时显示出一定的疗效。潜在的作用机制包括增强脑再灌注、溶栓和血栓切除术、降低血压和细胞保护。
在由护理人员在院前招募的超急性疑似脑卒中患者中，测试四天透皮给予甘油三硝酸酯（每天 5 毫克）与假治疗相比的安全性和疗效。
850 例患者的样本量将允许使用 90%的功效和 5%的显著性（双侧），以 0.70 的比值比（甘油三硝酸酯与假治疗，有序逻辑回归）检测改良 Rankin 量表的变化。
快速干预与甘油三硝酸酯治疗高血压性卒中试验-2（RIGHT-2）是一项多中心英国前瞻性随机假对照结局盲平行组试验，纳入 850 例超急性（发病后≤4 小时）FAST 阳性疑似卒中且收缩压≥120mmHg 的患者，这些患者在拨打 999 急救电话后由救护车服务转运。通过安全的互联网网站进行数据收集，具有实时数据验证。
主要结局是 90 天时通过电话进行的改良 Rankin 量表评分，结果对治疗进行了盲法评估。次要结局包括：血压、损伤、复发、吞咽困难、急性病变的神经影像学标志物，包括血管通畅性、出院安置、住院时间、死亡、认知、生活质量和情绪。神经影像学和严重不良事件的评估对治疗进行了盲法处理。
RIGHT-2 已从英国的七个救护车服务机构招募了超过 500 名参与者。
试验正在进行中。
英国心脏基金会。
ISRCTN26986053。
