UMIN-CTR Clinical Trial

Public title

Impact of Acarbose Therapy in Abnormal Glucose Tolerance Patients
with Coronary Artery Disease

Acronym

ATAC Study

Scientific Title

Impact of Acarbose Therapy in Abnormal Glucose Tolerance Patients
with Coronary Artery Disease

Scientific Title:Acronym

ATAC Study

Region

Japan

Condition

coronary artery disease with diabetes, including impaired glucose tolerance

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

It has also been reported that a fair percentage of patients with some cardiovascular diseases have abnormal glucose tolerance such as diabetes mellitus and impaired glucose tolerance, and that those patients have an ominous prognosis.
The aim of this study is to examine how the early improvement of glucose toxicity with administration of acarbose, postprandial hyperglycemia improving drug, to those cases, affects the development of cardiovascular events such as recurrence and deteriorating of angina and anti-atherogenic action by echo finding.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

incidence of cardiovascular events: new onset myocardial infarction, worsening anginal status and/or angiographic restenosis

Carotid intima-medial thickness(IMT)

Key secondary outcomes

1-1)Ultrasonic echo cardiography(IVS; Interventricular Septal Thickness, EF; Ejection Fraction, E/A, LVDd; Left Ventricular Diastolic dimension)
2-1)HbA1c
2-2)IRI
2-3)blood glucose levels
2-4)HOMA-R,HOMA-beta
3)Plasma lipid profile

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Acarbose is initiated before each meal with 50mg/time, 3 times/day, and increased to 100mg/time after examining tolerability if there is no enough therapeutic effect. However, the dosage shall be determined by their personal doctors.

Interventions/Control_2

Diet and exercise

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients who were found at catheterization test to have more than 50 % of stenosis, diagnosed with diabetic (including IGT) at 75g oral glucose tolerance test : 140mg/dl or more, HbA1c : less than 6.5%) are assigned to groups with or without Acarbose for comparison.

1) Subjects who are hyperlipidemic or who require administration of statin

Key exclusion criteria

Any subject who applies to the article below shall be excluded.
1) Patients on oral antidiabetic or insulin preparation
2) Patients with a history of ileus or undergone laparotomy
3) Patients with severe liver dysfunction or renal dysfunction
4) Patients with serious case of ketosis or diabetical coma, or precoma
5) Patients with severe infection disease, or in the perioperative period, or with extreme trauma
6) Patients with gastrointestinal problems such as diarrhea, vomiting
7) Patients with a history of sensitivity to Acarbose
8) Pregnant or possibly pregnant women
9) Patients judged by the investigator/subinvestigator to be ineligible for some other
reason

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Masato Watarai

Organization

Cardiovascular Center,Anjo Kosei Hospital

Division name

Division of Cardiology

Zip code

Address

28 Higashi-hirokute, Anjyo-cho, Anjyo

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Cardiovascular Center,Anjo Kosei Hospital

Division name

Division of Cardiology

Zip code

Address

TEL

0566-75-2111

Homepage URL

Email

Institute

Cardiovascular Center,Anjo Kosei Hospital

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2007

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2006

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2006

Year

11

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 related information

Registered date

2006

Year

12

Month

08

Day

Last modified on

2010

Year

06

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000658