Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
- Conditions
- Coronary Artery DiseaseHypertension
- Interventions
- Drug: control systolic blood pressure less than 120 mmHgDrug: control systolic blood pressure less than 140 mmHg
- Registration Number
- NCT01230216
- Lead Sponsor
- Takeshi Morimoto
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- coronary artery diseases which require coronary angiography or percutaneous coronary intervention
- primary hypertension (systolic blood pressure 140-180mmHg within one month)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intensive blood pressure control control systolic blood pressure less than 120 mmHg systolic blood pressure less than 120 mmHg standard blood pressure control control systolic blood pressure less than 140 mmHg systolic blood pressure less than 140 mmHg
- Primary Outcome Measures
Name Time Method change of percent atheroma volume 1.5-year change of percent atheroma volume measured by intravascular ultrasound
- Secondary Outcome Measures
Name Time Method all cause death 1.5-year Death from any cause
cardiac death 1.5-year Death from cardiac diseases
cardiovascular death 1.5-year Death from cardiovascular diseases
myocardial infarction 1.5-year myocardial infarction defined by ARC
stroke 1.5-year both ischemic and hemorrhagic strokes excluding transient ischemic attack
target-lesion revascularization 1.5-year target-lesion revascularization
hospitalization due to angina pectoris 1.5-year hospitalization due to angina pectoris
hospitalization due to heart failure 1.5-year hospitalization due to heart failure
any coronary revascularization 1.5-year any coronary revascularization
change of total atheroma volume 1.5-year change of total atheroma volume measured by intravascular ultrasond
percent change of total atheroma volume 1.5-year percent change of total atheroma volume measured by intravascular ultrasound
change of atheroma volume at most severe 10mm lesion 1.5-year change of atheroma volume at most severe 10mm lesion measured by intravascular ultrasound
Trial Locations
- Locations (1)
Division of Cardiology, Kyoto University Hospital
🇯🇵Kyoto, Japan