Multicentre Randomised trial of Acute Stroke treatment in the Ambulance with a nitroglycerine Patch - MR ASAP

niversity Medical Center Utrecht (UMCU)0 个研究点目标入组 1,400 人开始时间: 2017年6月27日最近更新: 2021年8月10日

适应症

试验速览

暂无简介。

•1.Age 18 years or older;
•2.Probable diagnosis of acute stroke, as made by the paramedic in the prehospital setting;
•3.Score of 2 or 3 on the Face Arm Speech Test (FAST);
•4.Systolic blood pressure = 140 mm Hg;
•5.Possibility to start the trial treatment within 3 hours of symptom onset;
•6.Intention to transport the patient to one of the participating hospitals;
•7.Written informed consent (deferred).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 700
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 700

•1.Considerable pre-stroke dependency in activities of daily living, defined as staying in a chronic nursing home or rehabilitation centre;
•2.Known glucose < 2.5 mmol/L;
•3.Witnessed seizure at presentation;
•4.Known life expectancy = 1 year;
•5.Known pregnancy or lactation;
•6.Clinical indication for treatment with GTN;
•7.Clinical indication for reduction of blood pressure;
•8.Known hypersensitivity to GTN, nitrates in general, or the adhesives used in the patch
•9.Glasgow Coma Scale < 8;
•10.Known with any of the following heart disorders: myocardial insufficiency due to obstruction; aortic or mitral valve stenosis; constrictive pericarditis; hypertrophic obstructive cardiomyopathy; cardiac tamponade;
•11.Known marked anaemia, defined as haemoglobin < 5 mmol/L;
•12.Known closed angle glaucoma;
•13.Known concomitant use of phosphodiesterase type-5 inhibitors, (e.g. sildenafil, tadalafil, vardenafil) or the soluble guanylate cyclase stimulator riociguat.

发起方

niversity Medical Center Utrecht (UMCU)