UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002576
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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&#8211;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
Email

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
Email

Sponsor
Institute Ogaki Municipal Hospital,department of cardiology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003141

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.