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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound

Conditions
-----------------
Coronary Artery Disease, Hypertension

Intervention / Treatment
-----------------
* Drug: control systolic blood pressure less than 120 mmHg
* Drug: control systolic blood pressure less than 140 mmHg


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intensive blood pressure control<br>systolic blood pressure less than 120 mmHg | Drug: control systolic blood pressure less than 120 mmHg<br>* use losartan to control blood pressure<br>|
| Active Comparator: standard blood pressure control<br>systolic blood pressure less than 140 mmHg | Drug: control systolic blood pressure less than 140 mmHg<br>* use losartan to control blood pressure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of percent atheroma volume | change of percent atheroma volume measured by intravascular ultrasound | 1.5-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause death | Death from any cause | 1.5-year | 
| cardiac death | Death from cardiac diseases | 1.5-year | 
| cardiovascular death | Death from cardiovascular diseases | 1.5-year | 
| myocardial infarction | myocardial infarction defined by ARC | 1.5-year | 
| stroke | both ischemic and hemorrhagic strokes excluding transient ischemic attack | 1.5-year | 
| target-lesion revascularization | target-lesion revascularization | 1.5-year | 
| any coronary revascularization | any coronary revascularization | 1.5-year | 
| hospitalization due to angina pectoris | hospitalization due to angina pectoris | 1.5-year | 
| hospitalization due to heart failure | hospitalization due to heart failure | 1.5-year | 
| change of total atheroma volume | change of total atheroma volume measured by intravascular ultrasond | 1.5-year | 
| percent change of total atheroma volume | percent change of total atheroma volume measured by intravascular ultrasound | 1.5-year | 
| change of atheroma volume at most severe 10mm lesion | change of atheroma volume at most severe 10mm lesion measured by intravascular ultrasound | 1.5-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery disease, hypertension