NCT00212004

Brief Summary

To evaluate whether the pioglitazone could reduce the recurrence of myocardial infarction (MI) in patients with DM and old myocardial infarction

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
630

participants targeted

Target at P75+ for phase_4 diabetes-mellitus

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_4 diabetes-mellitus

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

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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
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

12 years

First QC Date

September 13, 2005

Last Update Submit

May 22, 2018

Conditions

Diabetes MellitusMyocardial Infarction

Keywords

diabetes mellitusmyocardial infarctionpioglitazone

Outcome Measures

Primary Outcomes (1)

  • The time till the first cardiovascular composite endpoint

    death from cardiovascular death, and the hospitalization due to nonfatal myocardial infarction, nonfatal unstable angina25, treatment with coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft) and cerebral infarction.

    2 years

Secondary Outcomes (7)

  • All cause mortality

    2 years

  • Hospitalization due to nonfatal myocardial infarction

    2 years

  • Hospitalization due to nonfatal unstable angina

    2 years

  • Hospitalization due to treatment with coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft)

    2 years

  • Hospitalization due to cerebral infarction

    2 years

  • +2 more secondary outcomes

Study Arms (2)

Pioglitazone

ACTIVE COMPARATOR

Participants in the pioglitazone group were administered a pioglitazone tablet (15 mg) once a day. In the event of the side effects such as oedema, the dosage of pioglitazone was reduced to half or a quarter of the original dosage. Otherwise, we tried to increase the dose of pioglitazone to 30mg/day.

Drug: pioglitazone

Control

ACTIVE COMPARATOR

Participants assigned to Control group were treated with diet and exercise therapy or sulfonylurea (SU) or other additional drugs than pioglitazone.

Other: control

Interventions

pioglitazoneDRUG
Pioglitazone
controlOTHER
Control

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabetes mellitus (fasting plasma glucose levels of\>126 mg/dL, or 2-hour 75g oral glucose tolerance test (OGTT) value of \>200 mg/dL, and HbA1c levels of\<6.5% (47.5 IFCC))
  • History of myocardial infarction
  • Age between 20-79 years old

You may not qualify if:

  • acute MI occurring within the last 7 days
  • New York Heart Association (NYHA) symptoms of no fewer II or with left ventricular ejection fraction of not more than 40%
  • suspected type I DM
  • scheduled coronary angioplasty or history of coronary artery bypass graft surgery
  • serious liver or kidney damage
  • history of allergy or drug hypersensitivity
  • arteriosclerosis obliterans with Fontaine stage III or worse
  • inability to understand and/or comply with study medications, procedures and/or follow-up or any conditions that may render the patient unable to complete the study in the opinion of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Location

MeSH Terms

Conditions

Diabetes MellitusMyocardial Infarction

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Masafumi Kitakaze, MD, PhD

    National Cerebral and Cardiovascular Center, Japan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Clinical Medicine and Development

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

April 1, 2005

Primary Completion

April 1, 2017

Study Completion

April 1, 2018

Last Updated

May 23, 2018

Record last verified: 2018-05

Locations

JP(1)