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This trial aims to assess, in patients aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk, the effects on the incidence of major cardiovascular events during the scheduled treatment period of greater reduction in blood pressure with a SBP target <120 mmHg versus <140 mmHg.
Full description
This study is a multicenter, open-label, randomized controlled trial, which will randomize participants aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk. The study will compare the effects on the incidence of major cardiovascular events of allocation to achieve an intensive SBP goal (SBP <120 mmHg) with a standard SBP goal (SBP <140 mmHg) in four years of follow up.
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Inclusion criteria
At least ≥50 years old, and
Systolic blood pressure (SBP): (having documentation of SBP to meet the criteria below on 2 consecutive visits)
Prior vascular disease or at high vascular risk
Previous myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), at least a 50% diameter stenosis of a coronary, chest pain with objective evidence of myocardial ischemia (load electrocardiogram or load image examination indicated myocardial ischemia)
Previous stroke
Carotid endarterectomy (CE), or carotid stenting
Peripheral artery disease (PAD) with revascularization
Abdominal aortic aneurysm (AAA) ≥5 cm with repair
Combine with no less than two risk factors below
Exclusion criteria
Known secondary cause of hypertension
An indication for a specific BP lowering medication that the participant is not taking and the participant has not been documented to be intolerant of the medication class
One minute standing SBP <110 mmHg (not applicable if unable to stand)
Arm circumference too large or small to allow accurate blood pressure measurement with available devices
Proteinuria defined as urine dipstick ≥2+ protein at screening
Glomerulonephritis treated with or likely to be treated with immunosuppressive therapy
eGFR <45 ml/min /1.73m2 or end-stage renal disease (ESRD)
Previous MI, stroke, or hospitalization for angina, PCI, CABG, CE or carotid stenting, PAD with revascularization, AAA≥5 cm with repair within last 3 months
Symptomatic heart failure within the past 6 months or documented left ventricular ejection fraction (by any method) <35%
PCI or CABG planned for the next 6 months
A medical condition likely to limit survival to less than 3 years, or a cancer (other than non-melanoma skin cancer) diagnosed and treated within the past two years that, in the judgment of local clinical investigators, would compromise a participant's ability to comply with the protocol and complete the trial
Any organ transplant
Pregnancy, breast-feeding, or of child-bearing potential and not using adequate contraception
Any factors judged by local clinic investigators to be likely to limit adherence to interventions. For example,
Currently participation in a clinical trial with an unlicensed drug or device
Living in the same household as an already randomized participant
Primary purpose
Allocation
Interventional model
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11,255 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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