UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000140
Receipt number R000000203
Scientific Title Acarbose for Secondary Prevention of Cardiovascular Events in Patients With Coronary Stenting and Abnormal Glucose Tolerance
Date of disclosure of the study information 2005/09/13
Last modified on 2009/03/31 17:54:59

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Basic information

Public title

Acarbose for Secondary Prevention of Cardiovascular Events in Patients With Coronary Stenting and Abnormal Glucose Tolerance

Acronym

Acarbose and Secondary Prevention after Coronary Stenting

Scientific Title

Acarbose for Secondary Prevention of Cardiovascular Events in Patients With Coronary Stenting and Abnormal Glucose Tolerance

Scientific Title:Acronym

Acarbose and Secondary Prevention after Coronary Stenting

Region

Japan


Condition

Condition

Abnormal Glucose Tolerance

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to determine whether the intervention to newly diagnosed abnormal glucose tolerance after coronary stenting will improve the long-term clinical outcome.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Cardiovascular event free survival time

Key secondary outcomes

1)Conversion of abnormal glucose tolerance to type 2 diabetes
2)All cause of death
3)Occurrence of every cardiovascular event
4)Occurrence of in-stent restenosis
5)Regression of intimal plus medial complex of the carotid artery
6)Change in fasting, 2-hour blood glucose and insulin level
7)Change in homeostatis model assessment of insulin resistance
8)Change in HbA1c
9)Change in lipid profile
10)Change in high sensitive CRP
11)Change in Body Mass Index and body weight


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine Behavior,custom

Interventions/Control_1

Acarbose with a standard lifestyle modification for five years

Interventions/Control_2

A standard lifestyle modification for five years

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1)Within 8 weeks since implantation of coronary artery stents for stable angina pectoris or acute coronary syndrome.
2)Abnormal Glucose Tolerance according to 75gOGTT.
3)HbA1c is less than 6.5%.
4)Age is between 20 and 75 (at time of consent).
5)Patients who can give informed consent themselves in writing.

Key exclusion criteria

1)Patients with abnormal glucose tolerance caused by other organic disorders such as pancreatitis, hemochromatosis, post pancreatectomy, hyperthyroidism, Cushing syndrome, Prader-Willi syndrome etc.
2)Patients with planned angioplasty.
3)Patients with uncontrollable congestive heart failure.
4)Less than 6 months since last episode of cerebral infarction.
5)Patients who have received medication for diabetes mellitus before.
6)AST(GOT) exceeding 100 IU/L or ALT(GPT) exceeding 100 IU/L.
7)Creatinine exceeding 2mg/dl.
8)Patients with a history of ileus or less than 6 months since celiotomy.
9)Pregnant women or those who plan pregnancy, or are in the lactation period.
10)Habitual drinker (more than 100ml/day of alcohol).
11)Patients with a history of gastrectomy.
12)Patients for whom it is impossible to follow up for 5 years.
13)Any other reason that the clinical supervisors or clinical researchers
may have for considering a case unsuitable for the study.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichi Tamita

Organization

Kobe City General Hospital

Division name

Division of Cardiology

Zip code


Address

4-6,Minatojima Nakamachi Chuoku, Kobe, Japan

TEL

078-302-4321

Email



Public contact

Name of contact person

1st name
Middle name
Last name Minako Katayama

Organization

Institute of Biomedical Research and Innovation

Division name

Department of Clinical Research Promotion

Zip code


Address

2-2, Minatojima Minamimachi Chuoku, Kobe, Japan

TEL

078-304-5200

Homepage URL


Email

minako.wk@gmail.com


Sponsor or person

Institute

Institute of Biomedical Research and Innovation

Institute

Department

Personal name



Funding Source

Organization

Institute of Biomedical Research and Innovation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Translational Research Informatics Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

BRI_CAD_04-02

Org. issuing International ID_1

Translational Research Informatics Center

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2005 Year 09 Month 13 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

No longer recruiting

Date of protocol fixation

2005 Year 04 Month 13 Day

Date of IRB


Anticipated trial start date

2005 Year 05 Month 01 Day

Last follow-up date

2013 Year 04 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

2005 Year 09 Month 08 Day

Last modified on

2009 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000203


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name