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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000576
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Cardiovascular Medicine
Kyushu University Faculty of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000692

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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