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临床试验/ISRCTN99503308
ISRCTN99503308已完成3 期

Multicentre Randomised trial of Acute Stroke treatment in the Ambulance with a nitroglycerin Patch

niversity Medical Center Utrecht0 个研究点目标入组 325 人开始时间: 2018年1月2日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
325

研究概览

简要总结

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31242931 protocol (added 28/06/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36058230/ (added 05/09/2022) 2019 Abstract results in https://doi.org/10.1177/2396987319848124 (added 13/02/2024) 2021 Abstract results in https://doi.org/10.1177/23969873211044666 (added 13/02/2024) 2022 Abstract results in https://doi.org/10.1177/23969873221087559 (added 13/02/2024)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Age 18 years or older
  • 2. Probable diagnosis of acute stroke, as assessed 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)

排除标准

  • 1. Considerable pre-stroke dependency in activities of daily living, defined as staying in a chronic nursing home or rehabilitation centre
  • 2. Known pregnancy or lactation
  • 3. Indication for acute treatment with nitroglycerin or known use of nitroglycerin in the previous 12 hours
  • 4. Indication for acute reduction of blood pressure
  • 5. Known hypersensitivity to GTN, nitrates in general, or the adhesives used in the patch
  • 6. Glasgow Coma Scale < 8
  • 7. 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
  • 8. Known marked anaemia, defined as haemoglobin < 5 mmol/L
  • 9. Known closed angle glaucoma
  • 10. Known concomitant use of phosphodiesterase type-5 inhibitors, (e.g. sildenafil, tadalafil, vardenafil)

研究者

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