Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Control | No Intervention | If the blood pressure of a participant elevates to above 140/90 mmHg, antihypertensive therapy will be provided. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Cai, MD, PhD | Contact | 13810615602 | caijun7879@126.com |
Not provided
Not provided
The collected data, study protocol, and SAP are planned to be shared after the study ends 5 years later.
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 4 years |
| 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 |
| CVD Death | Cardiovascular death includes fatal coronary heart disease, fatal stroke, death from heart failure, and sudden cardiac death. | 4 Years |
| Advanced to Stage 2 Hypertension | the proportion of participants with blood pressure increasing to above 140/90 mmHg. | 4 Years |