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.

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.

scholarly journals Cerebral Microbleeds and the Effect of Intensive Blood Pressure Reduction on Hematoma Expansion and Functional Outcomes

2018 ◽  
Vol 75 (7) ◽  
pp. 850 ◽  
Author(s):  
Ashkan Shoamanesh ◽  
Andrea Morotti ◽  
Javier M. Romero ◽  
Jamary Oliveira-Filho ◽  
Frieder Schlunk ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Functional Outcomes ◽  
Blood Pressure Reduction ◽  
Cerebral Microbleeds ◽  
Hematoma Expansion ◽  
Pressure Reduction ◽  
Intensive Blood Pressure

scholarly journals A trial of blood pressure reduction in acute stroke

2000 ◽  
Vol 29 (6) ◽  
pp. 554-555 ◽  
Author(s):  
Philip M. W. Bath ◽  
Chris Weaver ◽  
Robert Iddenden ◽  
Fiona J. Bath
Keyword(s):  
Blood Pressure ◽  
Acute Stroke ◽  
Blood Pressure Reduction ◽  
Pressure Reduction

Modest Blood Pressure Reduction with Valsartan in Acute Ischemic Stroke: A Prospective, Randomized, Open-Label, Blinded-End-Point Trial

2015 ◽  
Vol 10 (5) ◽  
pp. 745-751 ◽  
Author(s):  
Mi Sun Oh ◽  
Kyung-Ho Yu ◽  
Keun-Sik Hong ◽  
Dong-Wha Kang ◽  
Jong-Moo Park ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Blood Pressure Reduction ◽  
Pressure Reduction ◽  
Open Label ◽  
End Point

scholarly journals INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lili Song ◽  
Xin Hu ◽  
Lu Ma ◽  
Xiaoying Chen ◽  
Menglu Ouyang ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Blood Pressure Reduction ◽  
Care Bundle ◽  
Pressure Reduction ◽  
Stepped Wedge ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Early intensive blood pressure (BP) lowering remains the most promising treatment for acute intracerebral hemorrhage (ICH), despite discordant results between clinical trials and potential variation in the treatment effects by approach to control BP. As the third in a series of clinical trials on this topic, the INTEnsive care bundle with blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT3) aims to determine the effectiveness of a goal-directed care bundle protocol of early physiological control (intensive BP lowering, glycemic control, and pyrexia treatment) and reversal of anticoagulation, in acute ICH. Methods INTERACT3 is a pragmatic, international, multicenter, stepped-wedge (4 phases/3 steps), cluster-randomized controlled trial to determine the effectiveness of a multifaceted care package in adult (age ≥ 18 years) patients (target 8360) with acute ICH (< 6 h of onset) recruited from 110 hospitals (average of 19 consecutive patients per phase) in low- and middle-income countries. After a control phase, each hospital implements the intervention (intensive BP lowering, target systolic < 140 mmHg; glucose control, target 6.1–7.8 mmol/L and 7.8–10.0 mmol/L in those without and with diabetes mellitus, respectively; anti-pyrexia treatment to target body temperature ≤ 37.5 °C; and reversal of anticoagulation, target international normalized ratio < 1.5 within 1 h). Information will be obtained on demographic and baseline clinical characteristics, in-hospital management, and 7-day outcomes. Central trained blinded assessors will conduct telephone interviews to assess physical function and health-related quality of life at 6 months. The primary outcome is the modified Rankin scale (mRS) at 6 months analyzed using ordinal logistic regression. The sample size of 8360 subjects provides 90% power (α = 0.05) to detect a 5.6% absolute improvement (shift) in the primary outcome of the intervention versus control standard care, with various assumptions. Discussion As the largest clinical trial in acute ICH, INTERACT3 is on schedule to provide an assessment of the effectiveness of a widely applicable goal-directed care bundle for a serious condition in which a clearly proven treatment has yet to be established. Trial registration ClinicalTrials.gov NCT03209258. Registered on 1 July 2017. Chinese Trial Registry ChiCTR-IOC-17011787. Registered on 28 June 2017

Detrimental effect of blood pressure reduction in the first 24 hours of acute stroke onset

Neurology ◽  
2003 ◽  
Vol 61 (8) ◽  
pp. 1047-1051 ◽  
Author(s):  
J. Oliveira-Filho ◽  
S.C.S. Silva ◽  
C.C. Trabuco ◽  
B.B. Pedreira ◽  
E.U. Sousa ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Acute Stroke ◽  
Detrimental Effect ◽  
Blood Pressure Reduction ◽  
Stroke Onset ◽  
Pressure Reduction

Intensive Blood Pressure Lowering in Patients with Moderate to Severe Grade Acute Cerebral Hemorrhage: Post Hoc Analysis of Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-2 Trial

2020 ◽  
Vol 49 (3) ◽  
pp. 244-252
Author(s):  
Adnan I. Qureshi ◽  
Lydia D. Foster ◽  
Iryna Lobanova ◽  
Wei Huang ◽  
Jose I. Suarez
Keyword(s):  
Blood Pressure ◽  
Scale Score ◽  
Cerebral Hemorrhage ◽  
Antihypertensive Treatment ◽  
Blood Pressure Reduction ◽  
Hematoma Expansion ◽  
Open Label ◽  
Disability Score ◽  
Severe Grade ◽  
Intensive Blood Pressure

Objective: To study the effect of intensive blood pressure reduction in patients with moderate to severe intracerebral hemorrhage (ICH) within the subjects recruited in Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 trial. Design: Randomized, multicenter, 2 group, open-label clinical trial. Setting: A total of 110 sites in the USA, Japan, China, Taiwan, South Korea, and Germany. Patients: A total of 1,000 patients underwent randomization from May 2011 till September 2015. Interventions: We analyzed the effect of intensive (goal 110–139 mm Hg) over standard (goal 140–179 mm Hg) systolic blood pressure (SBP) reduction using intravenous nicardipine within 4.5 h of symptom onset in moderate to severe grade subjects with ICH in a non-prespecified analysis. Moderate to severe grade was defined by Glasgow Coma Scale score <13 or baseline National Institutes of Health Stroke Scale score ≥10 or baseline intraparenchymal hemorrhage volume ≥30 mL or presence of intraventricular hemorrhage. The primary outcome was death or disability (score 4–6 on the modified Rankin scale) at 3 months after randomization ascertained by a blinded investigator. Measurements and Main Results: Of a total of 682 subjects who met the definition of moderate to severe grade (mean age 61.9 ± 13.1 years, 62.5% men) with a mean baseline SBP of 174.7 ± 24.8 mm Hg, the frequency of hematoma expansion was significantly lower among subjects randomized to intensive SBP reduction than among subjects randomized to standard SBP reduction (20.4 vs. 27.9%, relative risk [RR]: 0.7; 95% confidence interval [CI]: 0.55–0.96). The primary endpoint of death or disability was observed in 52.5% (170/324) of subjects receiving intensive SBP reduction and 48.9% (163/333) of subjects receiving standard SBP reduction (RR: 1.1; 95% CI: 0.9–1.2). Conclusions: Intensive SBP lowering reduced the frequency of hematoma expansion but did not reduce the rate of death or disability in patients with moderate to severe grade ICH.

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