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

January 7, 2016 updated by: Takeshi Morimoto
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 6066-8507
        • Division of Cardiology, Kyoto University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intensive blood pressure control
systolic blood pressure less than 120 mmHg
Drug: control systolic blood pressure less than 120 mmHg
use losartan to control blood pressure
Active Comparator: standard blood pressure control
systolic blood pressure less than 140 mmHg
Drug: control systolic blood pressure less than 140 mmHg
use losartan to control blood pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of percent atheroma volume
Time Frame: 1.5-year
change of percent atheroma volume measured by intravascular ultrasound
1.5-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all cause death
Time Frame: 1.5-year
Death from any cause
1.5-year
cardiac death
Time Frame: 1.5-year
Death from cardiac diseases
1.5-year
cardiovascular death
Time Frame: 1.5-year
Death from cardiovascular diseases
1.5-year
myocardial infarction
Time Frame: 1.5-year
myocardial infarction defined by ARC
1.5-year
stroke
Time Frame: 1.5-year
both ischemic and hemorrhagic strokes excluding transient ischemic attack
1.5-year
target-lesion revascularization
Time Frame: 1.5-year
target-lesion revascularization
1.5-year
any coronary revascularization
Time Frame: 1.5-year
any coronary revascularization
1.5-year
hospitalization due to angina pectoris
Time Frame: 1.5-year
hospitalization due to angina pectoris
1.5-year
hospitalization due to heart failure
Time Frame: 1.5-year
hospitalization due to heart failure
1.5-year
change of total atheroma volume
Time Frame: 1.5-year
change of total atheroma volume measured by intravascular ultrasond
1.5-year
percent change of total atheroma volume
Time Frame: 1.5-year
percent change of total atheroma volume measured by intravascular ultrasound
1.5-year
change of atheroma volume at most severe 10mm lesion
Time Frame: 1.5-year
change of atheroma volume at most severe 10mm lesion measured by intravascular ultrasound
1.5-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeshi Morimoto

Investigators

  • Principal Investigator: Takeshi Kimura, MD, PhD, Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

October 28, 2010

First Submitted That Met QC Criteria

October 28, 2010

First Posted (Estimate)

October 29, 2010

Study Record Updates

Last Update Posted (Estimate)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C464

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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