ISRCTN99414122
Completed
N/A
A prospective, collaborative, international, multicentre, randomised, parallel-group, single and outcome blinded, controlled, factorial trial to investigate the safety and efficacy of treatment with transdermal glyceryl trinitrate, a nitric oxide donor, and of continuing or stopping temporarily pre-stroke antihypertensive therapy, in patients with acute stroke
niversity of Nottingham (UK)0 sites3,500 target enrollmentNovember 12, 2002
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Acute stroke
- Sponsor
- niversity of Nottingham (UK)
- Enrollment
- 3500
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with acute ischaemic or haemorrhagic stroke within 48 hours
- •2\. Systolic blood pressure 140\-220 mmHg
Exclusion Criteria
- •1\. Unconscious (Glasgow Coma Scale less than eight)
- •2\. Definite need for nitrate therapy: concurrent myocardial infarction, unstable angina, left ventricular failure
- •3\. Dehydration
- •4\. Contraindication to nitrate therapy: hypersensitivity to nitrates, hypovolaemia, hypertrophic obstructive cardiomyopathy, aortic stenosis, cardiac tamponade, constrictive pericarditis, mitral stenosis, marked anaemia, closed\-angle glaucoma, sildenafil (Viagra) within previous 24 hours
- •5\. Systolic blood pressure less than 140 mmHg or more than 220 mmHg
- •6\. Patients expected to require surgical intervention (e.g. clot evacuation, carotid endarterectomy) during the treatment or follow\-up period
- •7\. Refusal to consent
- •8\. Patient dependent on others prior to stroke (e.g. Rankin score more than three)
- •9\. Known intracerebral pathology other than ischaemic stroke, e.g. subarachnoid haemorrhage, brain tumour, cerebral abscess
- •10\. Other serious condition which is likely to prevent outcome assessment, e.g. advanced cancer
Outcomes
Primary Outcomes
Not specified
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