UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003620 |
|---|---|
| Receipt number | R000004362 |
| Scientific Title | Effects of Aggressive Lipid Lowering Therapy With Atorvastatin on the Fibrous cap Thickness of Thin-cap Fibroatheroma: Three-Vessel Optical Coherence Tomography and Intravascular Ultrasound Study |
| Date of disclosure of the study information | 2010/05/17 |
| Last modified on | 2018/12/01 21:00:59 |
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Basic information
Public title
Effects of Aggressive Lipid Lowering Therapy With Atorvastatin on the Fibrous cap Thickness of Thin-cap Fibroatheroma: Three-Vessel Optical Coherence Tomography and Intravascular Ultrasound Study
Acronym
Effects of Aggressive Lipid Lowering Therapy With Atorvastatin on the Fibrous cap Thickness of Thin-cap Fibroatheroma: Three-Vessel Optical Coherence Tomography and Intravascular Ultrasound Study
Scientific Title
Effects of Aggressive Lipid Lowering Therapy With Atorvastatin on the Fibrous cap Thickness of Thin-cap Fibroatheroma: Three-Vessel Optical Coherence Tomography and Intravascular Ultrasound Study
Scientific Title:Acronym
Effects of Aggressive Lipid Lowering Therapy With Atorvastatin on the Fibrous cap Thickness of Thin-cap Fibroatheroma: Three-Vessel Optical Coherence Tomography and Intravascular Ultrasound Study
Region
| Japan |
Condition
Condition
Acute Coronary Syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is an exploratory study aiming to elucidate the mechanism underlying plaque stabilization of statin treatment using Optical Coherence Tomography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For the plaques evaluated by OCT, what are the differences in plaque-stabilizing effects of atorvastatin in plaques with different characteristics (fibrous cap thickness)?
Key secondary outcomes
1. Are LDL-C and fibrous-cap thickness inversely-correlated?
2. Are plaque volume and fibrous-cap thickness inversely-correlated?
3. Does atorvastatin suppress new plaque formation?
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
10 to 20 mg pitavastatin daily started within 24 hours of PCI to maintain LDL-cho level less than 70mg/dl
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
1. Patients with acute coronary syndrome (including ST-segment elevation acute myocardial infarction, non-ST-segment elevation myocardial infarction and unstable angina).
2. Patients who have at least one critical stenosis involving 75% or more of the stenosis
3. LDL-cho level between 100mg/dl and 180mg/dl
4. Patients providing written consent for participation in this clinical trial on their own volition after receiving a thorough explanation about the study
Key exclusion criteria
1. Patients who will undergo elective percutaneous coronary intervention,
2. Patients who received thrombolytic therapy
3. Previous statin treatment
4. Severe left ventricular dysfunction (Ejection fraction <40% by echocardiogram),
5. Uncontrolled severe diabetes mellitus (HbA1c >12.0%).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohru Masuyama |
Organization
Hyogo College of Medicine
Division name
Cardiovascular Division
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL
0798-45-6553
Public contact
Name of contact person
| 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, Hyogo 6638501 JAPAN
TEL
0798-45-6553
Homepage URL
kfujii@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Cardiovascular Division
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
| 2010 | Year | 05 | Month | 17 | 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 | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | 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 | 05 | Month | 16 | Day |
Last modified on
| 2018 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004362
