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

NCT ID: NCT01230216

Last Updated: 2016-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2015-04-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intensive blood pressure control

systolic blood pressure less than 120 mmHg

Group Type ACTIVE_COMPARATOR

control systolic blood pressure less than 120 mmHg

Intervention Type DRUG

use losartan to control blood pressure

standard blood pressure control

systolic blood pressure less than 140 mmHg

Group Type ACTIVE_COMPARATOR

control systolic blood pressure less than 140 mmHg

Intervention Type DRUG

use losartan to control blood pressure

Interventions

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control systolic blood pressure less than 120 mmHg

use losartan to control blood pressure

Intervention Type DRUG

control systolic blood pressure less than 140 mmHg

use losartan to control blood pressure

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeshi Morimoto

OTHER

Sponsor Role lead

Responsible Party

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Takeshi Morimoto

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Takeshi Kimura, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Locations

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Division of Cardiology, Kyoto University Hospital

Kyoto, Kyoto, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 36398903 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32905623 (View on PubMed)

Other Identifiers

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C464

Identifier Type: -

Identifier Source: org_study_id

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