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. 2022 Nov 18;2022(11):CD010315. doi: 10.1002/14651858.CD010315.pub5

RESPECT 2019.

Methods Prospective, multicentre, open, blinded endpoint, randomized clinical trial that included 140 hospitals in Japan between 20 October 2010 and 7 December 2016.
Follow‐up: 3.9 years
Participants Aged 50–85 years, independent ambulation, SBP 130–180 mmHg or DBP 80–110 mmHg on a regimen of 0–3 antihypertensive medications, and a history of stroke within the previous 3 years (evidence of an acute disturbance of focal neurological functions, with symptoms lasting > 24 hours, and symptomatic ischaemic stroke or intracerebral haemorrhage confirmed by MRI or computed tomography). Participation required written informed consent, and approval was provided by all local ethics committees for human research.
Exclusion criteria: people in whom stroke onset occurred within previous month.
Interventions Standard target: SBP < 140/90 mmHg or < 130/80 mmHg for people with diabetes, CKD, or history of MI
Lower target: SBP < 120/80 mmHg
Outcomes Primary endpoint: recurrent stroke, including ischaemic stroke and intracerebral haemorrhage. Recurrent stroke was clinically defined as a focal neurological deficit persisting for > 24 hours, as confirmed by MRI or computed tomography. Stroke was deemed fatal if death occurred within 30 days.
Secondary endpoints: reductions in ischaemic stroke, subtype of ischaemic stroke (including atherothrombotic infarction, cardioembolic infarction, lacunar infarction, or infarction due to other and unknown aetiology), intracerebral haemorrhage, subarachnoid haemorrhage, TIA, acute MI defined by standard criteria (compatible clinical history with changes on ECG or in cardiac enzyme concentration), composite cardiovascular events (cardiovascular death, non‐fatal stroke, and non‐fatal MI), all‐cause death, and the composite of all‐cause death, non‐fatal stroke, and non‐fatal MI. Cardiovascular death was defined as sudden death, fatal stroke, fatal MI, fatal CHF, or death attributed to other CVD. All reported efficacy outcomes were confirmed by a central adjudication committee that was blinded to treatment assignment. Serious adverse events were defined as those that were fatal or life‐threatening, that resulted in clinically significant or persistent disability, that required hospitalization, or that were judged as a significant hazard or harm that required medical or surgical interventions.
Notes Participants assigned to a standard target < 130/80 mmHg should be excluded from our database because they overlap with our lower target criteria (≤ 135/85 mmHg). To date, we have been unable to obtain individual participant data from the study authors to resolve this issue.