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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004320
Receipt No. R000005174
Scientific Title Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Date of disclosure of the study information 2010/10/04
Last modified on 2012/09/27

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Basic information
Public title Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Acronym Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Scientific Title Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Scientific Title:Acronym Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Region
Japan

Condition
Condition Hypertension, Coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of intensive blood pressure control on progression of atherosclerosis by intravascular ultrasound.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of percent atheroma volume evaluated by intravascular ultrasound after 18 months.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intensive blood pressure control (SBP<120mmHg)
Interventions/Control_2 Standard blood pressure control (SBP<140mmHg)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients who are planning to take CAG or PCI.
2)Patients with primary hypertention: SBP140-180mmHg within one month.
3)20<=Age<80
Key exclusion criteria 1)Patients with severe hypertention.
2)Patients with secondary hypertension.
3)Patients treated hypertention with more than 3 drugs.
4)Patients with coronary artery disease in left main trank.
5)Patients with moderate heart failure.
6)Patients with severe valvelar disease.
7)Patients with liver dysfunction.
8)Patients with renal dysfuction(Cr>=2.0 mg/dL).
9)Pregnant or nursing woman.
10)Patients with uncontrollable arrythmia.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kimura
Organization Kyoto University
Division name Cardiovascular Medicine
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto University
Division name Cardiovascular Meicine
Zip code
Address
TEL 0757514255
Homepage URL
Email

Sponsor
Institute Cardiovascular Medicine, Kyoto University
Institute
Department

Funding Source
Organization Research Institute for Production Development
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2010 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 04 Day
Last modified on
2012 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005174

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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