UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002886 |
|---|---|
| Receipt number | R000003521 |
| Scientific Title | The Impact of Eicosapentaenoic Acid Pretreatment on Periprocedural Microcirculatory Damage in Patients Undergoing Percutaneous Coronary Intervention |
| Date of disclosure of the study information | 2009/12/13 |
| Last modified on | 2018/12/01 20:59:01 |
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Basic information
Public title
The Impact of Eicosapentaenoic Acid Pretreatment on Periprocedural Microcirculatory Damage in Patients Undergoing Percutaneous Coronary Intervention
Acronym
The Impact of Eicosapentaenoic Acid Pretreatment on Periprocedural Microcirculatory Damage in Patients Undergoing Percutaneous Coronary Intervention
Scientific Title
The Impact of Eicosapentaenoic Acid Pretreatment on Periprocedural Microcirculatory Damage in Patients Undergoing Percutaneous Coronary Intervention
Scientific Title:Acronym
The Impact of Eicosapentaenoic Acid Pretreatment on Periprocedural Microcirculatory Damage in Patients Undergoing Percutaneous Coronary Intervention
Region
| Japan |
Condition
Condition
Patients with stable angina pectoris who undergo percutaneous coronary intervention
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of eicosapentaenoic acid pretreatment on post-procedural microvascular damage by intracoronary pressure/temperature sensor-tipped guide wire.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in index of microcirculatory index
Key secondary outcomes
1)Absolute value of the CK-MB and high-sensitive troponin I measured at 8 and 24 hours after PCI
2)Absolute and percent changes of lipid profiles
3)Absolute and percent changes of high-sensitive CRP, VCAM-1, and MMP-9
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
pravastatin treatment (1800mg daily) 4 weeks before elective PCI
Interventions/Control_2
no pretreatment
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)Stable angina pectoris
2)Culprit lesion involving 75% or more of the stenosis
3)Patients with dyslipidemia: LDL-cho >=100mg/dL and patients who are judged by the investigator as needing cholesterol lowering therapy
4)Patients providing written consent for participation in this clinical trial on their own volition after receiving a thorough explanation of the study
Key exclusion criteria
1)Target PCI lesion is left main coronary artery
2)Target PCI lesion is graft stenosis or in-stent restenosis
3)Patients on hemodialysis
4)Patients with acute coronary syndrome
5)Patients with contraindication of antiplatelet of anticoagulation drug
6)Patients with a history of hypersensitivity to any of the components of the product
7)Patients who are judged by the principal investigator to be ineligible for enrollment in the study
Target sample size
100
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
Sponsor or person
Institute
Cardiovascular Division, Hyogo College of Medicine
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 | 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
| 2009 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | 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
| 2009 | Year | 12 | Month | 13 | 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=R000003521
| 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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| Registered date | File name |
