Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20,000
- 主要终点
- Cardiovascular Disease
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Treatment
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.
干预措施: RASI and/or a single pill combination based RASI (Drug)
结局指标
主要结局
Cardiovascular Disease
时间窗: 4 years
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.
次要结局
- Stroke ( ischemic or hemorrhagic)(4 years)
- CVD Death(4 Years)
- Acute coronary syndrome(4 Years)
- Advanced to Stage 2 Hypertension(4 Years)
研究者
Jun Cai
MD, PhD
Chinese Academy of Medical Sciences, Fuwai Hospital