Skip to content

Efficacy of nitric oxide in stroke

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN99414122
Enrollment
3500
Registered
2002-11-12
Start date
2004-01-01
Completion date
Unknown
Last updated
2017-08-28

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

Conditions

Acute stroke Circulatory System Stroke, not specified as haemorrhage or infarction

Interventions

1. Glyceryl trinitrate (transdermal) 2. Continue/temporarily stop prior anti-hypertensive therapy

Sponsors

University of Nottingham (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with acute ischaemic or haemorrhagic stroke within 48 hours 2. Systolic blood pressure 140-220 mmHg

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Death and dependency (Rankin score more than two).

Secondary

MeasureTime frame
1. Events by 7 days - recurrent stroke, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, blood pressure daily between 1 and 7 days 2. Hospital events - length of stay in hospital, discharge disposition (death, institution or home) 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 4. Safety measures - death at 7 and 90 days, symptomatic intracranial haemorrhage at 7 days, major extracranial haemorrhage at 10 days

Countries

Australia, Canada, China, Denmark, Egypt, Georgia, Greece, Hong Kong, India, Ireland, Italy, Malaysia, New Zealand, Norway, Philippines, Poland, Romania, Singapore, Spain, Sri Lanka, Sweden, Turkey, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026