Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound (PREVUS)
Primary Purpose
Coronary Artery Disease, Hypertension
Status
Terminated
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
control systolic blood pressure less than 120 mmHg
control systolic blood pressure less than 140 mmHg
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, hypertension
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
Sites / Locations
- Division of Cardiology, Kyoto University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
intensive blood pressure control
standard blood pressure control
Arm Description
systolic blood pressure less than 120 mmHg
systolic blood pressure less than 140 mmHg
Outcomes
Primary Outcome Measures
change of percent atheroma volume
change of percent atheroma volume measured by intravascular ultrasound
Secondary Outcome Measures
all cause death
Death from any cause
cardiac death
Death from cardiac diseases
cardiovascular death
Death from cardiovascular diseases
myocardial infarction
myocardial infarction defined by ARC
stroke
both ischemic and hemorrhagic strokes excluding transient ischemic attack
target-lesion revascularization
target-lesion revascularization
any coronary revascularization
any coronary revascularization
hospitalization due to angina pectoris
hospitalization due to angina pectoris
hospitalization due to heart failure
hospitalization due to heart failure
change of total atheroma volume
change of total atheroma volume measured by intravascular ultrasond
percent change of total atheroma volume
percent change of total atheroma volume measured by intravascular ultrasound
change of atheroma volume at most severe 10mm lesion
change of atheroma volume at most severe 10mm lesion measured by intravascular ultrasound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01230216
Brief Title
Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Acronym
PREVUS
Official Title
Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow patients enrollment
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Takeshi Morimoto
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Hypertension
Keywords
coronary artery disease, hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intensive blood pressure control
Arm Type
Active Comparator
Arm Description
systolic blood pressure less than 120 mmHg
Arm Title
standard blood pressure control
Arm Type
Active Comparator
Arm Description
systolic blood pressure less than 140 mmHg
Intervention Type
Drug
Intervention Name(s)
control systolic blood pressure less than 120 mmHg
Intervention Description
use losartan to control blood pressure
Intervention Type
Drug
Intervention Name(s)
control systolic blood pressure less than 140 mmHg
Intervention Description
use losartan to control blood pressure
Primary Outcome Measure Information:
Title
change of percent atheroma volume
Description
change of percent atheroma volume measured by intravascular ultrasound
Time Frame
1.5-year
Secondary Outcome Measure Information:
Title
all cause death
Description
Death from any cause
Time Frame
1.5-year
Title
cardiac death
Description
Death from cardiac diseases
Time Frame
1.5-year
Title
cardiovascular death
Description
Death from cardiovascular diseases
Time Frame
1.5-year
Title
myocardial infarction
Description
myocardial infarction defined by ARC
Time Frame
1.5-year
Title
stroke
Description
both ischemic and hemorrhagic strokes excluding transient ischemic attack
Time Frame
1.5-year
Title
target-lesion revascularization
Description
target-lesion revascularization
Time Frame
1.5-year
Title
any coronary revascularization
Description
any coronary revascularization
Time Frame
1.5-year
Title
hospitalization due to angina pectoris
Description
hospitalization due to angina pectoris
Time Frame
1.5-year
Title
hospitalization due to heart failure
Description
hospitalization due to heart failure
Time Frame
1.5-year
Title
change of total atheroma volume
Description
change of total atheroma volume measured by intravascular ultrasond
Time Frame
1.5-year
Title
percent change of total atheroma volume
Description
percent change of total atheroma volume measured by intravascular ultrasound
Time Frame
1.5-year
Title
change of atheroma volume at most severe 10mm lesion
Description
change of atheroma volume at most severe 10mm lesion measured by intravascular ultrasound
Time Frame
1.5-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takeshi Kimura, MD, PhD
Organizational Affiliation
Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology, Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
6066-8507
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
36398903
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.
Results Reference
derived
PubMed Identifier
32905623
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.
Results Reference
derived
Learn more about this trial
Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
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