Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound (PREVUS)

Takeshi Morimoto

Status and phase: Terminated; Phase 4

Conditions: Hypertension; Coronary Artery Disease

Treatments: Drug: control systolic blood pressure less than 120 mmHg; Drug: control systolic blood pressure less than 140 mmHg

Study type: Interventional

Funder types: Other

Identifiers

NCT01230216

C464

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary artery disease.

Full description

Antihypertensive therapy is reported to reduce cardiovascular events in patients with coronary artery disease. The goal of blood pressure in patients with coronary artery disease is recommended to control below 140/90mmHg. However, the effect of intensive blood pressure control compared to standard blood pressure control is still unknown. The purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary atherosclerosis after 18 months. The goal of systolic blood pressure is under 120mmHg in intensive blood pressure control group and under 140mmHg in standard blood pressure control group. The design of this study is randomized control study.

Enrollment: 8 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• coronary artery diseases which require coronary angiography or percutaneous coronary intervention
• primary hypertension (systolic blood pressure 140-180mmHg within one month)

Exclusion criteria

• severe hypertension
• secondary hypertension
• treated with more than three antihypertensive drugs
• left main trunk trunk coronary artery disease
• moderate heart failure
• severe valvular disease
• liver dysfunction renal dysfunction (Cr>=2.0mg/dl) Pregnant or nursing women severe arrhythmia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

8 participants in 2 patient groups

intensive blood pressure control

Active Comparator group

Description:

systolic blood pressure less than 120 mmHg

Treatment:

Drug: control systolic blood pressure less than 120 mmHg

standard blood pressure control

Active Comparator group

Description:

systolic blood pressure less than 140 mmHg

Treatment:

Drug: control systolic blood pressure less than 140 mmHg