cerebrovascular accident stroke
Conditions
Interventions
The treatment group will receive a transdermal nitroglycerin patch 5 mg/day
during 1 day plus standard stroke care. The control group will receive standard
stroke care alone.
clinical trial
nitroglycerin
stroke
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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).
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcome at 90 days as assessed with the modified Rankin Scale (mRS). | — |
Secondary
| Measure | Time frame |
|---|---|
| On admission to the hospital: - Vital signs: first measured systolic and diastolic blood pressure, pulse, and body temperature; - Collateral circulation, as assessed with CTA (only in patients in whom CT angiography is performed as part of routine clinical care); - Lesion size: volume of the perfusion deficit (only in patients in whom CT perfusion is performed as part of routine clinical care) or ICH on the initial CT; At 24 hours (± 4 hours): - Treatment with intravenous thrombolysis; - Intra-arterial treatment; - Vital signs: systolic and diastolic blood pressure, pulse, and body temperature; - Neurological deficit, as assessed with the NIHSS. At 7 days (± 1 day) or at discharge, if earlier: - SAEs in the first 7 days or until discharge, if earlier; At 90 days (± 14 days): - Death; - Dichotomized mRS of 0-1 vs. 2-6; - Dichotomized mRS of 0-2 vs. 3-6; - Dichotomized mRS of 0-3 vs. 4-6; - Disability assessed with the score on the Barthel Index (BI); - Quality of life assessed with the EuroQol 5D-5L (EQ-5D-5L); - Home time: the number of nights among the first 90 since stroke onset that are spent in the patient*s own home or a relative*s home; - Patient location over first 90 days (± 14 days): hospital; rehabilitation service; chronic nursing facility; home. | — |
Countries
The Netherlands
Outcome results
None listed