UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002799 |
|---|---|
| Receipt number | 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 15:17:09 |
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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
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
k-toyama@kumamoto-u.ac.jp
Sponsor or person
Institute
Division of Cardiology, Health Insurance Hitoyoshi General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003405
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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