UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000576 |
|---|---|
| Receipt number | R000000692 |
| Scientific Title | Double-blind Placebo-controlled Trial on the Effects of Statin prior to Percutaneous Coronary Interventions studied in Japanese subjects |
| Date of disclosure of the study information | 2007/01/31 |
| Last modified on | 2010/08/19 18:09:15 |
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Basic information
Public title
Double-blind Placebo-controlled Trial on the Effects of Statin prior to Percutaneous Coronary Interventions studied in Japanese subjects
Acronym
Pre-PCI Statin Effect Study
Scientific Title
Double-blind Placebo-controlled Trial on the Effects of Statin prior to Percutaneous Coronary Interventions studied in Japanese subjects
Scientific Title:Acronym
Pre-PCI Statin Effect Study
Region
| Japan |
Condition
Condition
Patients with Ischemic Heart Disease who will undergo PCI
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this research is, to clarify whether or not treatment with relatively high doses of statin within the Japanese approved dose range given prior to PCI would improve prognosis in Japanese patients who will undergo PCI regardless of baseline LDL-C levels by conducting a randomized double-blind controlled clinical trial in order to determine positioning of statin for the treatment in Japanese patients with coronary artery diseases.
In this research, whether or not early initiation of the treatment with statin prior to PCI would decrease the incidences of complications caused by PCI will be primarily investigated. Also, the incidences of cardiovascular events and restenosis, etc. up to 6 months after the operation will be investigated as the secondary endpoint.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Occurence of postprocedural increase of CK-MB >2 times above the upper normal limit or increase of troponin-T above the upper normal limit. Occurence of re-elevation of those factors as for cases with baseline elevation
Key secondary outcomes
Occurence of all major adverse cardiac events (death, acute myocardial infarction, unplanned cardiac catheterization a/o revascularization, hospitalization due to worsened angina) from the time of entry to 6 months of follow-up
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
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
Following determination of lipid levels at baseline, rosuvastatin 5 mg will be given once daily for 7 days prior to PCI and 14 days after PCI regardless of baseline levels. Administration of lipid-lowering agents other than statin is allowed for the treatment of hyperlipidemia if the investigator judges it necessary during the treatment with the study drug. After completion of the treatment with the study drug, medication for hyperlipidemia including statin will be given to let patients achieve the guideline target of LDL-C <100 mg/dL in accordance with the 2002 JAS Guidelines for the Diagnosis and Treatment of Arteriosclerotic Cardiovascular Diseases
Interventions/Control_2
Following determination of lipid levels at baseline, a placebo will be given once daily for 7 days prior to PCI and 14 days after PCI regardless of baseline levels. Administration of lipid-lowering agents other than statin is allowed for the treatment of hyperlipidemia if the investigator judges it necessary during the treatment with the study drug. After completion of the treatment with the study drug, medication for hyperlipidemia including statin will be given to let patients achieve the guideline target of LDL-C <100 mg/dL in accordance with the 2002 JAS Guidelines for the Diagnosis and Treatment of Arteriosclerotic Cardiovascular Diseases
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
Patients untreated with statin for at least 2 weeks who will undergo PCI
Key exclusion criteria
Cases that requires emergent revascularization such as STEMI.
Cases with grave complications such as pulmonary edema or cardiogenic shock.
Cases with severe hyperlipidemia such as familial hypercholesterolemia who should be treated with statin.
High risk cases for rhabdomyolysis such as hypothyroidism or taking fibrates.
Pregnant or nursing female cases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Todaka |
Organization
Kyushu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL
092-642-5360
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Todaka |
Organization
Kyushu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Cardiovascular Medicine
Kyushu University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2007 | Year | 01 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2006 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 07 | 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
| 2007 | Year | 01 | Month | 19 | Day |
Last modified on
| 2010 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000692
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