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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002799
Receipt No. R000003405
Scientific Title Possible role of Statin treatment on Exercise Training in Patient with Cardiovascular Disease
Date of disclosure of the study information 2009/11/25
Last modified on 2009/12/27

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Basic information
Public title Possible role of Statin treatment on Exercise Training in Patient with Cardiovascular Disease
Acronym PRESET-CVD
Scientific Title Possible role of Statin treatment on Exercise Training in Patient with Cardiovascular Disease
Scientific Title:Acronym PRESET-CVD
Region
Japan

Condition
Condition Cardiovascular Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 comparison of hydrophilic and lipophilic statin treatment on lipid profile in cardiovascular disease patients with exercise rehabilitation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum lipids (Triglyceride, high-density lipoprotein, low-density lipoprotein) at 4 and 20weeks after randomization
Key secondary outcomes Parameter of glycolipid and inflammation, Metabolic Marker,
Assessment of cardiac function by echocardiography, Assessment of arterial stiffness by PWV/ABI, Assessment of exercise and cardiopulmonary function by cardiopulmonary exercise testing

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 Lowering low-density lipoprotein with rousvastatin under 100mg/dl according to Japan Atherosclerosis Society Guidelines
Interventions/Control_2 Lowering low-density lipoprotein with atorvastatin under 100mg/dl according to Japan Atherosclerosis Society Guidelines
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1)stable cardiovascular disease patients
2)subjects who gave written informed consent
Key exclusion criteria 1)history of side effect in statin therapy
2)impossible to exercise
3)history of allergy against other drugs
4)history of low pulmonary function and lung disease
5)history of severe hepatic and renal disturbance
6)Pregnant
7)poor compliance of medication
8)subjects whose doctor in charge do not agree to join the trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisao Ogawa
Organization Graduate School of Medical Science, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto 860-8556, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kensuke Toyama
Organization Graduate School of Medical Science, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address
TEL
Homepage URL
Email k-toyama@kumamoto-u.ac.jp

Sponsor
Institute Division of Cardiology, Health Insurance Hitoyoshi General Hospital
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 11 Month 25 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 03 Month 10 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 25 Day
Last modified on
2009 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003405

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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