ISRCTN99503308
Completed
Phase 3
Multicentre Randomised trial of Acute Stroke treatment in the Ambulance with a nitroglycerin Patch
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Acute ischaemic stroke and intracerebral haemorrhage
- Sponsor
- niversity Medical Center Utrecht
- Enrollment
- 325
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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