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

Cardiovascular Diseases Clinical Trial

— STEP-Pre  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05564780
• Other study ID #: 2022-GSP-GG-5
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2022
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Jun Cai, MD, PhD
• Phone: 13810615602
• Email: caijun7879[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Outcome

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