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NCT Number: NCT05564780

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

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.

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Key information

Conditions

Cardiovascular Diseases Hypertension Vascular Diseases

Age range

35 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RASI and/or a single pill combination based RASI

Drug

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 outcomes

  1. Cardiovascular Disease

    Time frame: 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.

Secondary outcomes

  1. Stroke ( ischemic or hemorrhagic)

    Time frame: 4 years

    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.

  2. Acute coronary syndrome

    Time frame: 4 Years

    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.

  3. CVD Death

    Time frame: 4 Years

    Cardiovascular death includes fatal coronary heart disease, fatal stroke, death from heart failure, and sudden cardiac death.

  4. Advanced to Stage 2 Hypertension

    Time frame: 4 Years

    the proportion of participants with blood pressure increasing to above 140/90 mmHg.

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Cai, MD, PhD

CONTACT

[email protected]

13810615602

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Acronym: STEP-Pre

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2022
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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