Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Overview
- Phase
- Phase 4
- Intervention
- control systolic blood pressure less than 120 mmHg
- Conditions
- Coronary Artery Disease
- Sponsor
- Takeshi Morimoto
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- change of percent atheroma volume
- Status
- Terminated
- Last Updated
- 10 years ago
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.
Investigators
Takeshi Morimoto
Professor
Kyoto University, Graduate School of Medicine
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
Arms & Interventions
intensive blood pressure control
systolic blood pressure less than 120 mmHg
Intervention: control systolic blood pressure less than 120 mmHg
standard blood pressure control
systolic blood pressure less than 140 mmHg
Intervention: control systolic blood pressure less than 140 mmHg
Outcomes
Primary Outcomes
change of percent atheroma volume
Time Frame: 1.5-year
change of percent atheroma volume measured by intravascular ultrasound
Secondary Outcomes
- all cause death(1.5-year)
- cardiac death(1.5-year)
- cardiovascular death(1.5-year)
- myocardial infarction(1.5-year)
- stroke(1.5-year)
- target-lesion revascularization(1.5-year)
- any coronary revascularization(1.5-year)
- hospitalization due to angina pectoris(1.5-year)
- hospitalization due to heart failure(1.5-year)
- change of total atheroma volume(1.5-year)
- percent change of total atheroma volume(1.5-year)
- change of atheroma volume at most severe 10mm lesion(1.5-year)