STEP-Pre is to investigate the benefits of using anti-hypertensive drugs in the population with a blood pressure of 130-139/80-89 mmHg and evaluate the health economics. STEP-Pre is a multi-center randomized clinical trial. The cohort will be randomized into the treatment group or control group with a 1:1 ratio. The treatment group will take anti-hypertensive medicine to control blood pressure under 130/80 mmHg. Both groups will take health care education. STEP-Pre will last 4 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
20,000
The participants in the Treatment group will begin with a single category antihypertensive drug to control their blood pressure, for example, perindopril. If the blood pressure cannot be controlled under 130/80 mmHg, another type of antihypertensive drug will be added.
Cardiovascular Disease
A composite end-point comprised of acute coronary syndrome (myocardial infarction and hospitalization for unstable angina), first occurrence of symptomatic stroke ( ischemic or hemorrhagic stroke), and death from cardiovascular causes.
Time frame: 4 years
Stroke ( ischemic or hemorrhagic)
Stroke is defined as a rapid onset of focal (or global) disturbance of cerebral function lasting more than 24 hours (except interrupted by surgery or death) without resolution of symptoms according to the World Health Organization. The diagnosis of stroke is confirmed by strict neurological examination, computed tomography (CT), or magnetic resonance imaging (MRI), and stroke subtypes are classified including ischemic or hemorrhagic, fatal or not fatal.
Time frame: 4 years
Acute coronary syndrome
Acute coronary syndrome includes myocardial infarction and hospitalization for unstable angina. The diagnosis of MI is based on the following criteria: (1) Patient has cardiac signs and symptoms, such as retrosternal pain last for at least 30 minutes, and not relieve to nitroglycerine during the attack; (2) Electrocardiographic abnormal findings of MI are observed; (3) Biochemical markers of cardiac damage are present. The diagnosis of unstable angina requires hospitalization for evaluation. The clinical presentation of unstable angina includes: (1) prolonged (\>20 min) angina pain at rest; (2) new onset angina; (3) post-MI angina; (4) recent destabilization of previously stable angina with at least Canadian Cardiovascular Society Class III angina characteristics.
Time frame: 4 Years
CVD Death
Cardiovascular death includes fatal coronary heart disease, fatal stroke, death from heart failure, and sudden cardiac death.
Time frame: 4 Years
Advanced to Stage 2 Hypertension
the proportion of participants with blood pressure increasing to above 140/90 mmHg.
Time frame: 4 Years
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