Rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2

Phase 3

Completed

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

• Registration Number: ISRCTN26986053
• Lead Sponsor: niversity of Nottingham

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30738649 results 2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28762896 protocol (added 28/11/2019) 2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/30475165 baseline characteristics (added 22/01/2020) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31587658 results (added 31/03/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36410799/ (added 22/11/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37564156/ 1 year post randomisation (added 14/08/2023) 2023 Results article in https://doi.org/10.1080/10903127.2023.2287171 Narrative data (added 01/12/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-05
• Study Completion: 2018-10-31
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1149

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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