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

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ClinicalTrials.gov Identifier: NCT01230216
Recruitment Status : Terminated (Slow patients enrollment)
First Posted : October 29, 2010
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Hypertension Drug: control systolic blood pressure less than 120 mmHg Drug: control systolic blood pressure less than 140 mmHg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Study Start Date : December 2010
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. change of percent atheroma volume [ Time Frame: 1.5-year ]
    change of percent atheroma volume measured by intravascular ultrasound


Secondary Outcome Measures :
  1. all cause death [ Time Frame: 1.5-year ]
    Death from any cause

  2. cardiac death [ Time Frame: 1.5-year ]
    Death from cardiac diseases

  3. cardiovascular death [ Time Frame: 1.5-year ]
    Death from cardiovascular diseases

  4. myocardial infarction [ Time Frame: 1.5-year ]
    myocardial infarction defined by ARC

  5. stroke [ Time Frame: 1.5-year ]
    both ischemic and hemorrhagic strokes excluding transient ischemic attack

  6. target-lesion revascularization [ Time Frame: 1.5-year ]
    target-lesion revascularization

  7. any coronary revascularization [ Time Frame: 1.5-year ]
    any coronary revascularization

  8. hospitalization due to angina pectoris [ Time Frame: 1.5-year ]
    hospitalization due to angina pectoris

  9. hospitalization due to heart failure [ Time Frame: 1.5-year ]
    hospitalization due to heart failure

  10. change of total atheroma volume [ Time Frame: 1.5-year ]
    change of total atheroma volume measured by intravascular ultrasond

  11. percent change of total atheroma volume [ Time Frame: 1.5-year ]
    percent change of total atheroma volume measured by intravascular ultrasound

  12. 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



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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230216


Locations
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Japan
Division of Cardiology, Kyoto University Hospital
Kyoto, Japan, 6066-8507
Sponsors and Collaborators
Takeshi Morimoto
Investigators
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Principal Investigator: Takeshi Kimura, MD, PhD Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
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Responsible Party: Takeshi Morimoto, Professor, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01230216    
Other Study ID Numbers: C464
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016
Keywords provided by Takeshi Morimoto, Kyoto University, Graduate School of Medicine:
coronary artery disease
hypertension
Additional relevant MeSH terms:
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Hypertension
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases