UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001112 |
|---|---|
| Receipt number | 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 23:18:08 |
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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
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
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001343
