NCT00212017

Brief Summary

The purpose of this study is to evaluate whether an alpha-glucosidase inhibitor, a drug for the suppression of postprandial hyperglycemia, could reduce the recurrence of myocardial infarction in patients with impaired glucose tolerance (IGT) and old myocardial infarction.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

7.2 years

First QC Date

September 13, 2005

Last Update Submit

August 20, 2018

Conditions

Impaired Glucose ToleranceMyocardial Infarction

Keywords

IGTMyocardial Infarctionalpha-glucosidase inhibitorre-infarction prevention

Outcome Measures

Primary Outcomes (1)

  • the time till the first cardiovascular composite endpoint of death from cardiovascular death, and hospitalization due to nonfatal myocardial infarction, nonfatal unstable angina[16], nonfatal stroke, or treatment with coronary revascularisation

    the time till the first cardiovascular composite endpoint of death from the time till the first cardiovascular composite endpoint of death from cardiovascular death, and hospitalization due to nonfatal myocardial infarction, nonfatal unstable angina\[16\], nonfatal stroke, or treatment with coronary revascularisation

    May 2005 and June 2012

Secondary Outcomes (7)

  • All cause mortality

    May 2005 and June 2012

  • Hospitalization due to coronary artery disease

    May 2005 and June 2012

  • Progression of IGT to diabetes

    May 2005 and June 2012

  • Development or deterioration of either hypertension or hyperlipidemia

    May 2005 and June 2012

  • Deterioration of renal function

    May 2005 and June 2012

  • +2 more secondary outcomes

Study Arms (2)

the voglibose group

ACTIVE COMPARATOR

Participants in the voglibose group were administered a voglibose tablet (0.2 mg) three times daily before meals.

Drug: voglibose

the control group

ACTIVE COMPARATOR

Participants assigned to the control group were treated only with diet and exercise therapy.

Behavioral: diet and exercise therapy

Interventions

vogliboseDRUG
the voglibose group
diet and exercise therapyBEHAVIORAL
the control group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Impaired glucose tolerance
  • History of myocardial infarction

You may not qualify if:

  • Type I diabetes
  • History of coronary artery bypass graft
  • Severe liver and/or kidney dysfunction
  • History of allergic response to drugs
  • Arteriosclerosis obliterans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Location

Related Publications (1)

  • Asakura M, Kim J, Asanuma H, Hamasaki T, Tsukahara K, Higashino Y, Ishikawa T, Nakama Y, Koba S, Maruyama Y, Tsujimoto M, Himeno H, Ohkusa T, Fujino S, Shimizu M, Endo T, Yoda S, Muroya T, Murohara T, Ohte N, Suzuki H, Kohno T, Fukui K, Shiono T, Takase H, Uzui H, Nagai Y, Hashimoto Y, Ikeda S, Mizuno S, Tamita K, Fujita M, Satake K, Kinoshita Y, Nunohiro T, Sakagami S, Higaki J, Morii I, Sawada R, Hiasa Y, Shigemasa T, Nakahama M, Sata M, Doi O, Ueda T, Yamada T, Yamanouchi T, Yamaguchi H, Morita Y, Hayashi H, Kitakaze M; ABC investigators. Does Treatment of Impaired Glucose Tolerance Improve Cardiovascular Outcomes in Patients with Previous Myocardial Infarction? Cardiovasc Drugs Ther. 2017 Aug;31(4):401-411. doi: 10.1007/s10557-017-6740-3.

    PMID: 28779371RESULT

MeSH Terms

Conditions

Glucose IntoleranceMyocardial Infarction

Interventions

vogliboseDietExercise Therapy

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Masafumi Kitakaze, MD, PhD

    National Cerebral and Cardiovascular Center, Japan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This is an open and blinded-endpoint study
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective, randomised, open, blinded-endpoint study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

April 1, 2005

Primary Completion

June 1, 2012

Study Completion

August 1, 2017

Last Updated

August 22, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)