Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RASI and/or a single pill combination based RASI.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases. Basic parameters: 35 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug RASI and/or a single pill combination based RASI
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.
Primary outcome measures
- Cardiovascular Disease [Time frame: 4 years]
Secondary outcome measures (4)
- Stroke ( ischemic or hemorrhagic) [Time frame: 4 years]
- Acute coronary syndrome [Time frame: 4 Years]
- CVD Death [Time frame: 4 Years]
- Advanced to Stage 2 Hypertension [Time frame: 4 Years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05564780 · 2022-GSP-GG-5