UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002576 |
|---|---|
| Receipt number | R000003141 |
| Scientific Title | Randomized Control Parallel Trial on the Effects of Atorvastatin Loading on Reduction of Myocardial Damage in Patients Undergoing Percutaneous Coronary Intervention |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2012/03/11 22:09:49 |
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Basic information
Public title
Randomized Control Parallel Trial on the
Effects of Atorvastatin Loading on Reduction of Myocardial Damage in Patients Undergoing Percutaneous Coronary Intervention
Acronym
Effects of Atorvastatin Loading on Reduction of Myocardial Damage in Patients Undergoing Percutaneous Coronary Intervention in Ogaki Municipal
Hospital.
Scientific Title
Randomized Control Parallel Trial on the
Effects of Atorvastatin Loading on Reduction of Myocardial Damage in Patients Undergoing Percutaneous Coronary Intervention
Scientific Title:Acronym
Effects of Atorvastatin Loading on Reduction of Myocardial Damage in Patients Undergoing Percutaneous Coronary Intervention in Ogaki Municipal
Hospital.
Region
| Japan |
Condition
Condition
Patients with Ischemic Heart Disease Undergoing PCI
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Examine the Effect of Atorvastatin Loading on Reduction for Myocardial Damage in Patients Undergoing Percutaneous Coronary Intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Major adverse cardiac events (MACE) (Cardiac death, nonfatal myocardial infarction, stroke, target vessel revascularization, slow flow during PCI) from the procedure up to 30 days.
*myocardial infarction :
increase of creatine kinase-MB > 2 times above the upper limit of normal. In patients with elevated baseline levels of creatine kinase-MB, myocardial infarction was defined as a subsequent increase of more than 2-fold in creatine kinase-MB from baseline value.
*Slow flow :Decline of TIMI Grade more than 1 grade during PCI
Key secondary outcomes
(1)Any postprocedural increase of markers of myocardial injury above upper limits of normal (creatine kinase-MB, troponin-I).
(2) The change from a baseline value of the following clinical markers (creatine kinase-MB, troponin-I, C-reactive protein, malondialdehyde-modified-LDL,LDL-C,HDL-C, apolipoprotein, oxidation stress ).
blood sampling periods:
(creatine kinase-MB, troponin-I, C-reactive protein);the day before PCI and at 8h and 24h and 30days after intervention.
(malondialdehyde-modified-LDL);
the day before PCI and at 24h after intervention.
(LDL-C,HDL-C, apolipoprotein, oxidation stress); the day before PCI and at 24h and 30days after intervention.
(3)The change of the platelet aggregation ability. blood sampling periods : the day before PCI and before PCI and at 24h and 30day after intervention.
(4)Evaluation of the plaque by IVUS.
(5)The patients with an additional written consent will be followed up for an additional year to investigate the incidence of MACE (primary end-point).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eligible patients receive atorvastatin (20mg loading dose given 12-18h before coronary angiography, followed by a further 20mg dose 2h before the procedure).
patients are treated with atorvastatin (10mg/day) from the next day after PCI to day 30.
Interventions/Control_2
Patients are treated with atorvastatin (10mg/day) from the next day after PCI to day 30.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients over 20 years old.
(2)Patients with ischemic heart disease undergoing PCI.
(3)Patients with LDL-Cholesterol over 70mg/dL.
(4)The patients who give an informed consent in writing.
Key exclusion criteria
(1)Patients with acute myocardial infarction with ST segment elevation
(2)Patients with non–ST segment elevation acute coronary syndrome with high-risk features warranting emergency coronary angiography
(3) Patients with increased plasma liver enzymes(AST or ALT >= 100 IU/L)
(4) Patients with left ventricular ejection fraction less than 30%
(5) Patients with renal failure (creatinine >3 mg/dl)
(6) Patients with a history of liver or muscle disease
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Mukawa |
Organization
Ogaki Municipal Hospital
Division name
Department of Cardiology
Zip code
Address
4-86 Minaminokawa-cho Ogaki Gifu
TEL
0584-81-3341
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori Kanzaki |
Organization
Ogaki Municipal Hospital
Division name
Department of Cardiology
Zip code
Address
4-86 Minaminokawa-cho Ogaki Gifu
TEL
0584-81-3341
Homepage URL
Sponsor or person
Institute
Ogaki Municipal Hospital,department of cardiology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
大垣市民病院(岐阜県)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | 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 | 10 | Month | 02 | Day |
Last modified on
| 2012 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003141
| 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 |
