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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002885
Receipt No. R000003513
Scientific Title The Impact of Pravastatin Pretreatment on Periprocedural Microcirculatory Damage After Percutaneous Coronary Intervention
Date of disclosure of the study information 2009/12/13
Last modified on 2011/05/18

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Basic information
Public title The Impact of Pravastatin Pretreatment on Periprocedural Microcirculatory Damage After Percutaneous Coronary Intervention
Acronym The Impact of Pravastatin Pretreatment on Periprocedural Microcirculatory Damage After Percutaneous Coronary Intervention
Scientific Title The Impact of Pravastatin Pretreatment on Periprocedural Microcirculatory Damage After Percutaneous Coronary Intervention
Scientific Title:Acronym The Impact of Pravastatin Pretreatment on Periprocedural Microcirculatory Damage After Percutaneous Coronary Intervention
Region
Japan

Condition
Condition Angina Pectoris
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effect of pretreatment of pravastatin on post-procedural microcirculation states with the use of an intracoronary pressure/temperature sensor-tipped guide wire in vivo.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes index of microcirculatory resistance by intracoronary pressure/temperature sensor-tipped guide wire
Key secondary outcomes CK-MB, Troponin I at 8 and 24 hours after PCI

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Drug: Pravastatin 20mg/day
Interventions/Control_2 Control
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 Patients with stable angina who will undergo PCI.
Plasma LDL cholesterol levels : >=100mg/dL and &#8804;160mg/dL
Atherosclerotic lesion of >75% stenosis
No history of statin administration
Key exclusion criteria Patients with an atherosclerotic lesion with >50% stenosis at a left main trunk
Contraindication of statin treatment
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Fujii
Organization Hyogo College of Medicine
Division name Cardiovascular Division
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya-city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hyogo College of Medicine
Division name Cardiovascular Division
Zip code
Address
TEL 0798-45-6553
Homepage URL
Email

Sponsor
Institute Cardiovascular DIvision
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 12 Month 13 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 Completed
Date of protocol fixation
2008 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2010 Year 01 Month 01 Day
Date of closure to data entry
2010 Year 01 Month 01 Day
Date trial data considered complete
2010 Year 01 Month 01 Day
Date analysis concluded
2010 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 12 Month 13 Day
Last modified on
2011 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003513

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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