Clinical trial NCT01230216: Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Official title: Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Hypertension
Keywords: coronary artery disease
hypertension
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2010-10-29
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change of percent atheroma volume
timeFrame: 1.5-year
Secondary outcomes:
measure: all cause death
timeFrame: 1.5-year
measure: cardiac death
timeFrame: 1.5-year
measure: cardiovascular death
timeFrame: 1.5-year
measure: myocardial infarction
timeFrame: 1.5-year
measure: stroke
timeFrame: 1.5-year
measure: target-lesion revascularization
timeFrame: 1.5-year
measure: any coronary revascularization
timeFrame: 1.5-year
measure: hospitalization due to angina pectoris
timeFrame: 1.5-year
measure: hospitalization due to heart failure
timeFrame: 1.5-year
measure: change of total atheroma volume
timeFrame: 1.5-year
measure: percent change of total atheroma volume
timeFrame: 1.5-year
measure: change of atheroma volume at most severe 10mm lesion
timeFrame: 1.5-year
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Division of Cardiology, Kyoto University Hospital
Study officials:
affiliation: Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
name: Takeshi Kimura, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
citation: Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.