scholarly journals Baseline characteristics of the 1149 patients recruited into the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) randomized controlled trial

2018 ◽  
Vol 14 (3) ◽  
pp. 298-305 ◽  
Author(s):  
Philip M Bath ◽  
Polly Scutt ◽  
Jason P Appleton ◽  
Mark Dixon ◽  
Lisa J Woodhouse ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Glyceryl Trinitrate ◽  
Acute Stroke ◽  
Controlled Trial ◽  
Nitric Oxide Donor ◽  
Main Trial ◽  
Randomized Controlled ◽  
Baseline Characteristics ◽  
The Uk ◽  
Stroke Trial

Background High blood pressure is common in acute stroke and associated with a worse functional outcome. Glyceryl trinitrate, a nitric oxide donor, lowers blood pressure in acute stroke and may improve outcome. Aims Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) tested the feasibility of performing a UK multicenter ambulance-based stroke trial, and the safety and efficacy of glyceryl trinitrate when administered by paramedics before hospital admission. Methods Paramedic-led ambulance-based multicenter prospective randomized single-blind blinded-endpoint parallel-group controlled trial of transdermal glyceryl trinitrate (given for four days) versus sham in patients with ultra-acute (<4 h) presumed stroke. Data are number (%), median (interquartile range) or mean (standard deviation). Results Recruitment ran from October 2015 to 31 May 2018. A total 1149 patients were recruited from eight UK ambulance services and taken to 54 acute hospitals. Baseline characteristics include: mean age 73 (15) years; female 555 (48%); median time from stroke to randomization 70 (45, 115) min; face-arm-speech scale score 2.6 (0.5); and blood pressure 162 (25)/92 (18) mmHg. The final diagnosis was ischemic stroke 52%, hemorrhagic stroke 13%, Transient Ischemic Attack (TIA) 9%, and mimic 25%. The main trial results will be presented in quarter 4 2018. The results will also be included in updated Cochrane systematic reviews, and individual patient data meta-analyses of all relevant randomized controlled trials. Conclusion It was feasible to perform a multicenter ambulance-based ultra-acute stroke trial in the UK and to treat with glyceryl trinitrate versus sham. The relatively unselected cohort of stroke patients is broadly representative of those admitted to hospital in the UK. Trial registration ISRCTN26986053.

Abstract WP390: Regional Differences in Blood Pressure Management After Acute Stroke in International Randomized Controlled Trials

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Lili Song ◽  
Lingli Sun ◽  
Xia Wang ◽  
Tom J Moullaali ◽  
Thompson G Robinson ◽  
...  
Keyword(s):  
Blood Pressure ◽  
South America ◽  
Acute Stroke ◽  
Sodium Nitroprusside ◽  
Regional Differences ◽  
Controlled Trial ◽  
Epidemiological Studies ◽  
Randomized Controlled ◽  
Stroke Study ◽  
To Receive

Background and Aims: Epidemiological studies show significant variations in hypertension management within and between countries. The level of regional variation in early blood pressure (BP) management after acute stroke is uncertain. Methods: Data are from the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED), a partial-factorial, international randomized controlled trial (RCT) of thrombolysis-eligible acute ischemic stroke (AIS) patients with systolic BP (SBP >150 mmHg) assigned to intensive (target SBP 130-140 mmHg) vs. guideline-recommended (SBP <180 mmHg) treatment; and INTERACT2, an international RCT of patients with spontaneous intracerebral hemorrhage (ICH) (<6 hours) with elevated SBP randomized to intensive (target SBP <140 mmHg) or guideline-recommended (SBP <180 mmHg) treatment. BP management was compared between five participating regions of these RCTs: west (Europe/Australia/US), China, other Asia (South Korea, Singapore, Thailand, Vietnam), India (India and Pakistan), and South America (Argentina, Chile, Brazil, Colombia). Results: There were 2196 AIS (38% women, mean age 67[12] years) and 2829 acute ICH (37% women, mean age 63[13] years) patients in these analyzes. Commonly used intravenous BP lowering agents are labetalol, nitroglycerin, and topical Nitrates in western countries; mannitol, urapidil, and sodium nitroprusside in China; nicardipine in other Asian countries; and sodium nitroprusside and labetalol in South America. Western patients were more likely to receive BP lowering treatment in the first 24 hours and treated with multiple agents, and had larger magnitude of SBP reduction and greater SBP variability. BP control parameters over 2-7 days were comparable between regions. Conclusion: Regional variations in early BP management in acute stroke translated into differences in magnitude of SBP reduction and SBP variability in patients.

scholarly journals Ambulance-delivered transdermal glyceryl trinitrate versus sham for ultra-acute stroke: Rationale, design and protocol for the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) trial (ISRCTN26986053)

2017 ◽  
Vol 14 (2) ◽  
pp. 191-206 ◽  
Author(s):  
Jason P Appleton ◽  
Polly Scutt ◽  
Mark Dixon ◽  
Harriet Howard ◽  
Lee Haywood ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Glyceryl Trinitrate ◽  
Acute Stroke ◽  
Sample Size ◽  
Modified Rankin Scale ◽  
Time Data ◽  
Serious Adverse Events ◽  
Discharge Disposition ◽  
Include Blood Pressure ◽  
Stroke Trial

Rationale Vascular nitric oxide levels are low in acute stroke and donors such as glyceryl trinitrate have shown promise when administered very early after stroke. Potential mechanisms of action include augmentation of cerebral reperfusion, thrombolysis and thrombectomy, lowering blood pressure, and cytoprotection. Aim To test the safety and efficacy of four days of transdermal glyceryl trinitrate (5 mg/day) versus sham in patients with ultra-acute presumed stroke who are recruited by paramedics prior to hospital presentation. Sample size estimates The sample size of 850 patients will allow a shift in the modified Rankin Scale with odds ratio 0.70 (glyceryl trinitrate versus sham, ordinal logistic regression) to be detected with 90% power at 5% significance (two-sided). Design The Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) is a multicentre UK prospective randomized sham-controlled outcome-blinded parallel-group trial in 850 patients with ultra-acute (≤4 h of onset) FAST-positive presumed stroke and systolic blood pressure ≥120 mmHg who present to the ambulance service following a 999 emergency call. Data collection is performed via a secure internet site with real-time data validation. Study outcomes The primary outcome is the modified Rankin Scale measured centrally by telephone at 90 days and masked to treatment. Secondary outcomes include: blood pressure, impairment, recurrence, dysphagia, neuroimaging markers of the acute lesion including vessel patency, discharge disposition, length of stay, death, cognition, quality of life, and mood. Neuroimaging and serious adverse events are adjudicated blinded to treatment. Discussion RIGHT-2 has recruited more than 500 participants from seven UK ambulance services. Status Trial is ongoing. Funding British Heart Foundation. Registration ISRCTN26986053.

scholarly journals INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lili Song ◽  
Chen Chen ◽  
Xiaoying Chen ◽  
Yijia Guo ◽  
Feifeng Liu ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Acute Stroke ◽  
Physical Function ◽  
Controlled Trial ◽  
Blood Pressure Reduction ◽  
Hematoma Expansion ◽  
Pressure Reduction ◽  
Open Label ◽  
Related Quality ◽  
Stroke Trial

Abstract Background Early pre-hospital initiation of blood pressure (BP) lowering could improve outcomes for patients with acute stroke, by reducing hematoma expansion in intracerebral hemorrhage (ICH), and time to reperfusion treatment and risk of intracranial hemorrhage in ischemic stroke (IS). We present the design of the fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4). Methods A multi-center, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) assessed trial of pre-hospital BP lowering in 3116 hypertensive patients with suspected acute stroke at 50+ sites in China. Patients are randomized through a mobile phone digital system to intensive BP lowering to a target systolic BP of < 140 mmHg within 30 min, or guideline-recommended BP management according to local protocols. After the collection of in-hospital clinical and management data and 7-day outcomes, trained blinded assessors conduct telephone or face-to-face assessments of physical function and health-related quality of life in participants at 90 days. The primary outcome is the physical function on the modified Rankin scale at 90 days, analyzed as an ordinal outcome with 7 categories. The sample size was estimated to provide 90% power (α = 0.05) to detect a 22% reduction in the odds of a worse functional outcome using ordinal logistic regression. Discussion INTERACT4 is a pragmatic clinical trial to provide reliable evidence on the effectiveness and safety of ambulance-delivered hyperacute BP lowering in patients with suspected acute stroke. Trial registration ClinicalTrials.gov NCT03790800. Registered on 2 January 2019; Chinese Trial Registry ChiCTR1900020534. Registered on 7 January 2019. All items can be found in this protocol paper.

The Effect of Transdermal Glyceryl Trinitrate, a Nitric Oxide Donor, on Blood Pressure and Platelet Function in Acute Stroke

2001 ◽  
Vol 11 (3) ◽  
pp. 265-272 ◽  
Author(s):  
Philip M.W. Bath ◽  
Rohan Pathansali ◽  
Robert Iddenden ◽  
Fiona J. Bath
Keyword(s):  
Nitric Oxide ◽  
Blood Pressure ◽  
Glyceryl Trinitrate ◽  
Acute Stroke ◽  
Platelet Function ◽  
Nitric Oxide Donor

scholarly journals Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’

2018 ◽  
Vol 3 (2) ◽  
pp. 193-196 ◽  
Author(s):  
Polly Scutt ◽  
Jason P Appleton ◽  
Mark Dixon ◽  
Lisa J Woodhouse ◽  
Nikola Sprigg ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Glyceryl Trinitrate ◽  
Acute Stroke ◽  
Statistical Analysis Plan ◽  
Nitric Oxide Donor ◽  
Experimental Stroke ◽  
Treatment Allocation ◽  
Parallel Group ◽  
Stroke Trial

Rationale: Glyceryl trinitrate, a nitric oxide donor, is a candidate treatment for acute stroke; it lowers blood pressure, does not alter cerebral blood flow or platelet function and is neuroprotective in experimental stroke. The ongoing rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 trial aims to assess the safety and efficacy of paramedic-delivered glyceryl trinitrate in patients with ultra-acute stroke. Aims and design: The rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 trial is a multicentre UK-based prospective randomised sham-controlled outcome-blinded parallel-group trial in patients with presumed stroke who present to the ambulance service following a 999 emergency call. The primary outcome is the modified Rankin scale measured by central telephone follow-up at 90 days. Results This paper describes the statistical analysis plan for the rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 trial and was developed prior to unblinding to treatment allocation. The statistical analysis plan includes details of methods for analyses and unpopulated tables and figures to be included in the primary and other secondary publications. Discussion Statistical analysis plan details what analyses will be done prior to unblinding to treatment allocation to avoid bias in the findings. Rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 trial will determine whether glyceryl trinitrate administered ultra-acutely can improve outcome after stroke. The rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 trial is registered as ISRCTN26986053.

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