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Register:	ISRCTN
Last refreshed on:	12 December 2023
Main ID:	ISRCTN26986053
Date of registration:	05/03/2015
Prospective Registration:	Yes
Primary sponsor:	University of Nottingham
Public title:	Rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2
Scientific title:	Rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 (RIGHT2): assessment of safety and efficacy of transdermal glyceryl trinitrate, a nitric oxide donor, and of the feasibility of a multicentre ambulance-based stroke trial
Date of first enrolment:	01/05/2015
Target sample size:	850
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN26986053
Study type:	Interventional
Study design:	Randomised; Interventional; Design type: Treatment (Treatment)
Phase:	Phase III

Countries of recruitment
England	United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Diane Havard
Address:	Nottingham City Hospital Division of Stroke Medicine The University of Nottingham Clinical Sciences Building, Hucknall Road NG5 1PB Nottingham United Kingdom
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients presenting to paramedics in context of 999 ambulance call for ‘stroke’
2. Age 18 years or more (there is no maximum age)
3. ‘Face/Arm/Speech’ Time (FAST) score >1
4. Time <=4 hours of onset
5. Systolic BP >=120 mmHg
6. Have provided informed consent, or a relative/paramedic has provided proxy consent
7. Paramedic is trained in RIGHT2 procedures, is from a participating ambulance station and will take patient to a participating comprehensive/primary stroke centre

Exclusion criteria:
1. Patient at a Nursing or Care Home
2. Glucose (BM stix) <2.5 mmol/l
3. Glasgow Coma Scale <8
4. Witnessed seizure/fit at presentation
5. Known life expectancy <6 months
6. Known to have taken a PDE5 inhibitor, such as sildenafil, in previous day before stroke
7. Known sensitivity to Transiderm Nitro patch
8. Known sensitivity to Duoderm hydrocolloid dressing

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Topic: Stroke; Subtopic: Acute Care; Disease: In hospital study
Circulatory System

Intervention(s)

Transdermal Glyceryl Trinitrate patch 5mg, daily for 4 days or sham patch for 4 days.

Primary Outcome(s)

Death/dependence/independence: 7-level modified Rankin Scale 90 days after stroke

Secondary Outcome(s)

Secondary ID(s)

18362

2015-000115-40

Source(s) of Monetary Support

British Heart Foundation

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; 15/EM/0055

Results

Results available:	Yes
Date Posted:
Date Completed:	31/10/2018
URL:

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