Multicentre Randomised trial of Acute Stroke treatment in the Ambulance with a nitroglycerin Patch
- Conditions
- cerebrovascular accidentstroke10007963
- Registration Number
- NL-OMON47827
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1400
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).
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Functional outcome at 90 days as assessed with the modified Rankin Scale (mRS).</p><br>
- Secondary Outcome Measures
Name Time Method