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

NCT01230216 | Terminated Phase 4 DMC

• 1 other identifier: C464
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Hypertension

Keywords

coronary artery disease; hypertension

Outcome Measures

Primary Outcomes (1)

• change of percent atheroma volume

  change of percent atheroma volume measured by intravascular ultrasound

  1.5-year

Secondary Outcomes (12)

• all cause death

  1.5-year

• cardiac death

  1.5-year

• cardiovascular death

  1.5-year

• myocardial infarction

  1.5-year

• stroke

  1.5-year

Study Arms (2)

intensive blood pressure control

ACTIVE COMPARATOR

systolic blood pressure less than 120 mmHg

Drug: control systolic blood pressure less than 120 mmHg

standard blood pressure control

ACTIVE COMPARATOR

systolic blood pressure less than 140 mmHg

Drug: control systolic blood pressure less than 140 mmHg

Interventions

control systolic blood pressure less than 120 mmHg DRUG

use losartan to control blood pressure

intensive blood pressure control

control systolic blood pressure less than 140 mmHg DRUG

use losartan to control blood pressure

standard blood pressure control

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• coronary artery diseases which require coronary angiography or percutaneous coronary intervention
• primary hypertension (systolic blood pressure 140-180mmHg within one month)

You may not qualify if:

• 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

Sponsors & Collaborators

• Takeshi Morimoto: lead

Study Sites (1)

Division of Cardiology, Kyoto University Hospital

Kyoto, Kyoto, 6066-8507, Japan

Location

Related Publications (2)

• 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.

  PMID: 36398903 DERIVED

• 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.

  PMID: 32905623 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Hypertension

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Takeshi Kimura, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: October 29, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

JP (1)