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

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 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


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

Value
https://center6.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