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

Multicentre Randomised trial of Acute Stroke treatment in the Ambulance with a nitroglycerine Patch - MR ASAP

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005086-31-NL

Enrollment

1400

Registered

2017-06-27

Start date

2017-10-19

Completion date

Unknown

Last updated

2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke MedDRA version: 20.0 Level: LLT Classification code 10042244 Term: Stroke System Organ Class: 100000004852

Interventions

Product Name: nitroglycerin Pharmaceutical Form: Transdermal patch

Eligibility

Sex/Gender

All

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). 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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of transdermal GTN, started within 3 hours of symptom onset in the prehospital setting, on functional outcome at 90 days in patients with acute ischaemic stroke or intracerebral haemorrhage.;Secondary Objective: To assess whether the effects of transdermal GTN, started within 3 hours of symptom onset in the prehospital setting, on functional outcome at 90 days are consistent across specific subgroups of patients, i.e., those with 1. ischaemic stroke; 2. ischaemic stroke treated with endovascular techniques; or 3. intracerebral haemorrhage. To assess the effect of GTN on collaterals, size of the ischemic core and salvageable brain tissue on admission to the hospital. To collect and analyse data regarding the deferred consent procedure and its association with patient recall and satisfaction at three months from randomisation. To study the efficiency of national IAT implementation, given the availability of IAT hospitals and capacity, and travel times of ambulance services. ;Primary end point(s): The primary outcome measure is the score on the modified Rankin Scale (mRS)54 at 90 days (± 14 days). The mRS is the preferred disability parameter for clinical trials in stroke. The mRS is an ordinal hierarchical scale incorporating six categories from 0 up to and including 5, and describes the range of disability encountered post stroke. ‘Death’ is assigned a score of 6.;Timepoint(s) of evaluation of this end point: 90 days	—

Measure

Time frame

Main Objective: To assess the effect of transdermal GTN, started within 3 hours of symptom onset in the prehospital setting, on functional outcome at 90 days in patients with acute ischaemic stroke or intracerebral haemorrhage.;Secondary Objective: To assess whether the effects of transdermal GTN, started within 3 hours of symptom onset in the prehospital setting, on functional outcome at 90 days are consistent across specific subgroups of patients, i.e., those with 1. ischaemic stroke; 2. ischaemic stroke treated with endovascular techniques; or 3. intracerebral haemorrhage. To assess the effect of GTN on collaterals, size of the ischemic core and salvageable brain tissue on admission to the hospital. To collect and analyse data regarding the deferred consent procedure and its association with patient recall and satisfaction at three months from randomisation. To study the efficiency of national IAT implementation, given the availability of IAT hospitals and capacity, and travel times of ambulance services. ;Primary end point(s): The primary outcome measure is the score on the modified Rankin Scale (mRS)54 at 90 days (± 14 days). The mRS is the preferred disability parameter for clinical trials in stroke. The mRS is an ordinal hierarchical scale incorporating six categories from 0 up to and including 5, and describes the range of disability encountered post stroke. ‘Death’ is assigned a score of 6.;Timepoint(s) of evaluation of this end point: 90 days

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Secondary

Measure	Time frame
Secondary end point(s): 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 Index56 (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. Resource use will be censored at 90 days. Where final follow-up occurs earlier, the last known placement will be extrapolated to 90 days; ? Patient location over first 90 days (± 14 days): hospital; rehabilitation service; chronic nursing facility; home. ;Timepoint(s) of evaluation of this end point: 90 days	—

Measure

Time frame

Secondary end point(s): 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 Index56 (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. Resource use will be censored at 90 days. Where final follow-up occurs earlier, the last known placement will be extrapolated to 90 days; ? Patient location over first 90 days (± 14 days): hospital; rehabilitation service; chronic nursing facility; home. ;Timepoint(s) of evaluation of this end point: 90 days

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Countries

Netherlands

Contacts

Public ContactTrial Office Neurology

University Medical Center Utrecht

mrasap@amc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026