Efficacy of Nitric Oxide in Stroke-2 (ENOS-2)

Phase 1

• Conditions: Hyperacute stroke - both ischaemic and haemorrhage; MedDRA version: 22.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 21.1Level: PTClassification code 10019016Term: Haemorrhagic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-001304-42-GB
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-10
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

•100 adults (=18 years) with ischaemic stroke and compatible CT (MR) scan.
•20 adults (=18 years) with imaging-confirmed intracerebral haemorrhage (ICH) and maximum haematoma length <5cm (recruited for safety only).
•Treatment 3-5 hours post ictus (or from when last seen free of stroke symptoms)
•Systolic BP >120 mmHg
•Waiver of consent for treatment to ensure GTN given in 3-5 hour time-window (and thrombolysis not delayed if ischaemic stroke).

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

•Patient from a nursing home
•Glucose (BM stix or equivalent) <3 mmol/l
•Glasgow coma scale <8
•Witnessed seizure at presentation
•Known life expectancy <6 months.
•Known stroke mimic, aneurysmal subarachnoid haemorrhage, or haemorrhage due to venous thrombosis
•Systolic blood pressure <120 mmHg
•Known allergy to glyceryl trinitrate (Transiderm Nitro) patch
•Known sensitivity to Duoderm hydrocolloid dressing
•Pregnant or breast-feeding
•Planned for palliative care only
•Known previous enrolment in ENOS-2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified