Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension
NCT ID: NCT05564780
Last Updated: 2022-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20000 participants
INTERVENTIONAL
2023-01-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
Control
If the blood pressure of a participant elevates to above 140/90 mmHg, antihypertensive therapy will be provided.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 35 - 64 years old
* Without taking antihypertensive medicine during screening
* Signed the written informed consent
Exclusion Criteria
* 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.
35 Years
64 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Responsible Party
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Jun Cai
MD, PhD
Central Contacts
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Other Identifiers
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2022-GSP-GG-5
Identifier Type: -
Identifier Source: org_study_id
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