Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Drug: RASI and/or a single pill combination based RASI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage 1 hypertension (blood pressure is in 130-139/80-89 mmHg); 35 - 64 years old Without taking antihypertensive medicine during screening Signed the written informed consent Exclusion Criteria: took antihypertensive medicine within the last 1 month; History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not lacunar infarction and transient ischemic attack [TIA]); History of myocardial infarction or unstable angina or history of coronary revascularization (PCI or CABG); Lab tests indicating abnormal liver or kidney function (ALT ≥ 3 times the upper limit of normal value, or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2); History of sustained atrial fibrillation or Ventricular arrhythmias at entry influencing the measurement of electronic blood pressure； Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial; Dilated or hypertrophic cardiomyopathy, rheumatic heart disease, or congenital heart disease; Severe somatic disease such as cancer; Severe cognitive impairment or mental disorders; pregnant or breastfeeding, or planning to be pregnant; having organ transplantation; Participating in other clinical trials.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Antihypertensive drugs will be provided to the participants in the arm, including RASI and/or a single pill combination based on RASI. If the blood pressure of a participant elevates to above 140/90 mmHg, antihypertensive therapy will be provided. | Drug: RASI and/or a single pill combination based RASI<br>* 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.<br>|
| No Intervention: Control<br>If the blood pressure of a participant elevates to above 140/90 mmHg, antihypertensive therapy will be provided. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 4 Years | 
| CVD Death | Cardiovascular death includes fatal coronary heart disease, fatal stroke, death from heart failure, and sudden cardiac death. | 4 Years | 
| Advanced to Stage 2 Hypertension | the proportion of participants with blood pressure increasing to above 140/90 mmHg. | 4 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage 1 Hypertension