NCT00221156

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2005

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

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

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

June 25, 2009

Status Verified

June 1, 2009

First QC Date

September 13, 2005

Last Update Submit

June 23, 2009

Conditions

Glucose Metabolism DisordersCoronary Artery Disease

Keywords

Abnormal Glucose Tolerancecoronary artery diseasediabetes mellitusclinical outcome

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular event free survival time

Secondary Outcomes (8)

  • Conversion of abnormal glucose tolerance to type 2 diabetes

  • All causes of death

  • Occurrence of every cardiovascular event

  • Occurrence of in-stent restenosis

  • Change in fasting, 2-hour blood glucose and insulin level

  • +3 more secondary outcomes

Interventions

AcarboseDRUG

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Within 8 weeks since implantation of coronary artery stents for stable angina pectoris or acute coronary syndrome.
  • Abnormal glucose tolerance according to a 75 g oral glucose tolerance test (OGTT).
  • HbA1c is less than 6.5%.
  • Age is between 20 and 75 years (at time of consent).
  • Patients who can give informed consent themselves in writing.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institute of Biomedical Research and Innovation.

Kobe, Hyogo Pref., 650-0047, Japan

Location

Kobe City General Hospital/Institute of Biomedical Research and Innovation

Kobe, Hyogo Pref., 650-0047, Japan

Location

Kawasaki Medical School Hospital

Kurashiki, Okayama-ken, 701-0192, Japan

Location

MeSH Terms

Conditions

Glucose Metabolism DisordersCoronary Artery DiseaseDiabetes Mellitus

Interventions

Acarbose

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • Koichi Tamita, MD.

    Division of Cardiology, Kobe General Hospital

    PRINCIPAL INVESTIGATOR

  • Minako Katayama, MD

    Division of Clinical Research Promotion, Institute of Biomedical Research and Innovation.

    STUDY DIRECTOR

  • Yutaka Furukawa, MD

    Division of Cardiology, Kobe General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

May 1, 2005

Study Completion

April 1, 2009

Last Updated

June 25, 2009

Record last verified: 2009-06

Locations

JP(3)