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

Hypertension Clinical Trial

— PREVUS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01230216
• Other study ID #: C464
• Status: Terminated
• Phase: Phase 4
• First received: October 28, 2010
• Last updated: January 7, 2016
• Start date: December 2010
• Est. completion date: April 2015

Study information

• Verified date: January 2016
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Hypertension
• Myocardial Ischemia

Intervention

Drug:
• control systolic blood pressure less than 120 mmHg
use losartan to control blood pressure
• control systolic blood pressure less than 140 mmHg
use losartan to control blood pressure

Locations

Country	Name	City	State
Japan	Division of Cardiology, Kyoto University Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Takeshi Morimoto

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of percent atheroma volume	change of percent atheroma volume measured by intravascular ultrasound	1.5-year	No
Secondary	all cause death	Death from any cause	1.5-year	Yes
Secondary	cardiac death	Death from cardiac diseases	1.5-year	Yes
Secondary	cardiovascular death	Death from cardiovascular diseases	1.5-year	Yes
Secondary	myocardial infarction	myocardial infarction defined by ARC	1.5-year	Yes
Secondary	stroke	both ischemic and hemorrhagic strokes excluding transient ischemic attack	1.5-year	Yes
Secondary	target-lesion revascularization	target-lesion revascularization	1.5-year	Yes
Secondary	any coronary revascularization	any coronary revascularization	1.5-year	Yes
Secondary	hospitalization due to angina pectoris	hospitalization due to angina pectoris	1.5-year	Yes
Secondary	hospitalization due to heart failure	hospitalization due to heart failure	1.5-year	Yes
Secondary	change of total atheroma volume	change of total atheroma volume measured by intravascular ultrasond	1.5-year	No
Secondary	percent change of total atheroma volume	percent change of total atheroma volume measured by intravascular ultrasound	1.5-year	No
Secondary	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	No