Efficacy of nitric oxide in stroke

Not Applicable

Completed

• Conditions: Acute stroke; Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN99414122
• Lead Sponsor: niversity of Nottingham (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11-12
• Last Update Posted: 28 August 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3500

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
11. Involvement in a trial of another experimental intervention (drug or surgery) for acute stroke
12. Not available for follow-up, e.g. no fixed address, overseas visitor
13. Females of childbearing potential, pregnancy or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death and dependency (Rankin score more than two).

Secondary Outcome Measures

Name	Time	Method
1. Events by 7 days - recurrent stroke, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, blood pressure daily between 1 and 7 days<br>2. Hospital events - length of stay in hospital, discharge disposition (death, institution or home)<br>3. Outcome at 90 days - Barthel Index (less than 60, including death), Barthel Index more than 95/100 at three months (good outcome), quality of life (EuroQol), abbreviated mental test score<br>4. Safety measures - death at 7 and 90 days, symptomatic intracranial haemorrhage at 7 days, major extracranial haemorrhage at 10 days