Study on the treatment with a nitroglycerin patch in the ambulance for patients with a stroke

Phase 1

• Conditions: Stroke; MedDRA version: 20.0Level: LLTClassification code 10042244Term: StrokeSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-005086-31-NL
• Lead Sponsor: niversity Medical Center Utrecht (UMCU)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-27
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

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

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified