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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001112
Receipt No. R000001343
Scientific Title Effect of pioglitazone on cardiovascular events in high-risk diabetic patients with acute brain infarction
Date of disclosure of the study information 2008/04/04
Last modified on 2010/11/04

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Basic information
Public title Effect of pioglitazone on cardiovascular events in high-risk diabetic patients with acute brain infarction
Acronym EPOCH study
Scientific Title Effect of pioglitazone on cardiovascular events in high-risk diabetic patients with acute brain infarction
Scientific Title:Acronym EPOCH study
Region
Japan

Condition
Condition Acute brain infarction with type2 diabetes mellitus.
Classification by specialty
Cardiology Endocrinology and Metabolism Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims of the study are to investigate whether pioglitazone can prevent cardiovascular events following acute brain infarction in patients with type2 diabetes mellitus.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Cardiovascular events (death, stroke, acute coronary syndrome).
Recurrence of brain infarction.
Key secondary outcomes Improvement of neurological deficits, ADL, cognitive functions, asymptomatic brain lesions, and progression of carotid lesions. Biochemical markers.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intervention: oral administration of pioglitazone 15mg per day.
Interventions/Control_2 Control: no use of thiazolidine derivatives.
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 Acute brain infarction (within 7 days after onset).
Complicated by type 2 diabetes mellitus.
Age equal to or more than 20 years.
Ability of oral food intake.
Given informed consent to the study.
Key exclusion criteria History of congestive heart failure (in case of suspicious patients, BNP>100 or ejection fraction less than 40%).
Administration of thiazolidine derivatives prior to onset.
History of adverse reaction to thiazolidine derivatives
liver dysfunction (hepatitis due to HBV, HCV, alcohol or increased titer of ALT exceeding 3 times of normal value).
Renal dysfunction (Cr>2.5).
HbA1c>9%.
Requirement for long-term insulin therapy (exclude temporary use of insulin).
Brain infarction due to unclassified causes such as dissection, moyamoya disease, etc.
Regarded as inadequate to entry for the study.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanari Kitazono
Organization Kyushu University Hospital
Division name Department of Medicine and Clinical Science
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5256
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyushu University Hospital
Division name Department of Medicine and Clinical Science
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kyushu University
Institute
Department

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
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
2008 Year 04 Month 04 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
2007 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2013 Year 12 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
2008 Year 04 Month 04 Day
Last modified on
2010 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001343

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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