ESH‐CHL‐SHOT 2014

Trial name or title	ESH‐CHL‐SHOT Study
Methods	Prospective, multinational, randomized trial, with a 3 x 2 factorial design: three different SBP targets; two different LDL‐C targets. The trial is designed as a Prospective, Randomized, Open‐Blind Endpoint evaluation (PROBE) trial. The expected mean follow‐up is 4 years
Participants	Men and women aged ≥ 65 years. Qualifying event is stroke or TIA 1 to 6 months prior to randomization. Untreated people should have SBP ≥ 140 mmHg and those on antihypertensive treatment could be included irrespective of their blood pressure. People not receiving statin treatment with LDL‐C > 2.8 mmol/L, and those on statin treatment with any LDL‐C value could be included. All participants should have antiplatelet therapy (or anticoagulant whenever indicated) unless contraindicated. Exclusion criteria included people with unstable clinical conditions; clinical disturbances caused by non stroke pathology; people with haemodynamically significant carotid stenosis or requiring carotid revascularization, secondary hypertension, SBP > 140 mmHg under three antihypertensive drugs at full doses and orthostatic hypotension, those with LDL‐C > 2.8 mmol/L under full dose of a statin, LDL‐C > 4.5 mmol/L under low dose of a statin or untreated, history of MI if baseline LDL‐C was < 1.8 mmol/L; dementia; severe disability (modified Rankin scale > 4); severe CKD defined as serum creatinine > 250 mmol/L
Interventions	Standard target: SBP < 135 to 145 mmHg Intensive target: SBP < 125 to 135 mmHg or < 125 mmHg
Outcomes	The primary endpoint is time to occurrence of (recurrent) stroke (fatal and non fatal). Secondary cardiovascular end points are time to occurrence of: First major cardiovascular event, a composite of cardiovascular death, non fatal stroke, non fatal MI, vascular interventions and hospitalised heart failure; CHD events, a composite of sudden death, fatal and non fatal MI, unstable angina, coronary interventions; all‐cause death; cardiovascular death, a composite of fatal stroke, fatal MI, sudden death, any other death attributed to CVD; hospitalized heart failure; new‐onset atrial fibrillation; ischaemic stroke; haemorrhagic stroke; and composite of stroke and TIA
Starting date	April 2013
Contact information	Alberto Zanchetti, Istituto Auxologico Italiano, Via L. Ariosto 13, 20145 Milan, Italy. Tel: +39 02 619112237; e‐mail: alberto.zanchetti@auxologico.it
Notes	The published byline includes 53 co‐authors; no reported conflicts of interest. The activity of the General Coordinating Centre in Milan is supported by institutional research funds of Fondazione Istituto Auxologico Italiano. It also collaborates the European Society of Hypertension and the Chinese Hypertension League