UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000091
Receipt number R000000133
Scientific Title The Japan Working Group for the Assessment That the Pioglitazone Protects DM Patients Against Re-Infarction
Date of disclosure of the study information 2005/08/31
Last modified on 2020/03/09 10:08:53

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Basic information

Public title

The Japan Working Group for the Assessment That the Pioglitazone Protects DM Patients Against Re-Infarction

Acronym

PPAR Study

Scientific Title

The Japan Working Group for the Assessment That the Pioglitazone Protects DM Patients Against Re-Infarction

Scientific Title:Acronym

PPAR Study

Region

Japan


Condition

Condition

DM patients(HbA1c < 6.5%) with the history of myocardial infarcion

Classification by specialty

Cardiology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time till the first cardiovascular composite endpoint of death from cardiovascular death, and the hospitalization due to nonfatal myocardial infarction, nonfatal unstable angina, treatment with coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft) and cerebral infarction.

Key secondary outcomes

(1) All cause mortality
(2) Hospitalization due to either of the component of primary endpoints
(3) Progression of diabetes (HbA1C levels > 7.0%)
(4) worsening of renal function ((1) All cause mortality
(2) Hospitalization due to either of the component of primary endpoints
(3) Progression of diabetes (HbA1C levels less than 7.0%)
(4) worsening of renal function (serum creatine levels =>2.5mg/dL or the increases of serum creatine levels by =>2mg/dL)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

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.

Interventions/Control_2

In control group, (1)each participated doctor (1)instructs weight reduction, appropriate diet, regular exercise and/or (2)prescribes sulfonylurea agents.

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

79 years-old >=

Gender

Male and Female

Key inclusion criteria

1.diabetes mellitus (HbA1c < 6.5%)
2.History of myocardial infarction

Key exclusion criteria

1.Symptomatic CHF
2.Type I diabetes
3.History of coronary artery bypass graft
4.Severe liver and/or kidney dysfunction
5.History of allergic response to drugs
6.arteriosclerosis obliterans

Target sample size

720


Research contact person

Name of lead principal investigator

1st name Masafumi
Middle name
Last name Kitakaze

Organization

National Cerabral and Cardiovascular Center

Division name

Cardiovascular Division

Zip code

565-8565

Address

5-7-1 Fujishirodai, Suita City, Osaka Pref. 565-8565, Japan

TEL

06-6833-5012

Email

kitakaze@zf6.so-net.ne.jp


Public contact

Name of contact person

1st name Masanori
Middle name
Last name Asakura

Organization

Clinical Study Support Center Japan (CSSCJ)

Division name

PPAR office

Zip code

565-8565

Address

5-7-1 Fujishirodai, Suita City, Osaka Pref. 565-8565

TEL

06-6836-0077

Homepage URL

http://www.csscj.com

Email

kitakaze@zf6.so-net.ne.jp


Sponsor or person

Institute

Department of Clinical Meidicine and Development, National Cerebral and Cardiovascular Center

Institute

Department

Personal name



Funding Source

Organization

Japan Heart Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB of NCVC

Address

5-7-1- Fujishirodai Suita

Tel

06-6833-5012

Email

matsuji@mgt.ncvc.go.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


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 08 Month 31 Day


Related information

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pubmed/31193597

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/31193597

Number of participants that the trial has enrolled

630

Results

The primary endpoint was observed in 14.2% and 14.1% patients in the control and pioglitazone groups during two years.

Results date posted

2020 Year 03 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2018 Year 10 Month 22 Day

Baseline Characteristics

630 patients with mild DM with a history of MI to undergo either DM therapy

Participant flow

Participants in the pioglitazone group were administered a pioglitazone tablet (15 mg) once a day. The dosage of pioglitazone was reduced to half or quarter of the original dosage if side effects, such as oedema, occurred. Otherwise, the dose of pioglitazone was increased to 30 mg/day. Participants assigned to the control group were treated with diet and exercise therapy or SUs or additional drugs other than pioglitazone.
Diet or exercise therapy was strengthened by expert nutritionists and/or physical therapists besides the attending physicians if DM exacerbated in patients in any of the groups. Concomitant use of SUs was permitted if the strengthened non-pharmacological therapies could no longer improve DM. Body weight, blood pressure, results of 75-g OGTT, HbA1c levels, serum triglyceride, and total cholesterol levels, plasma BNP levels, left ventricular ejection fraction (LVEF), LV diastolic parameter (E/A) and LV deceleration time by echocardiography were measured, and medications were documented at baseline and at 24 months. All data were compiled at the data centre in the NTT Data (Tokyo, Japan) and G-ONE (Osaka, Japan).

Adverse events

The frequencies of additional adverse events in the control and pioglitazone groups were 123 vs. 127 events. The major detailed adverse events were as follows: gastrointestinal disorders (7 vs. 8 events); hepatic disorders (2 vs. 2 events); respiratory disorders (2 vs. 4 events); benign and malignant disorders (11 vs. 5 events), including bladder cancer (1 vs. 0 events); metabolic, endocrine, and nutritional disorders (20 vs. 15 events), including hypoglycaemia (1 vs. 0 events); nervous system disorders (9 vs. 2 events); ophthalmological disorders (3 vs. 2 events); infectious disorders (4 vs. 6 events); renal and urinary disorders (2 vs. 4 events); cardiac disorders (41 vs. 51 events), including HF (2 vs. 7 events); vascular disorders (5 vs. 5 events) and oedema (2 vs. 10 events) in the control and pioglitazone groups, respectively.

Outcome measures

The primary outcome was the time until the first cardiovascular composite endpoint of death from cardiovascular death, hospitalisation due to nonfatal MI, nonfatal unstable angina, treatment with coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft) and cerebral infarction. Secondary outcomes were an all-cause death, each factor of the primary endpoints, DM progression (HbA1c levels less than 7.0%) and worsening of renal function (serum creatine levels > 2.5 mg/dL or increase in serum creatine levels by less than 2 mg/dL).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2004 Year 11 Month 01 Day

Date of IRB

2005 Year 04 Month 01 Day

Anticipated trial start date

2005 Year 04 Month 01 Day

Last follow-up date

2014 Year 12 Month 31 Day

Date of closure to data entry

2017 Year 04 Month 30 Day

Date trial data considered complete

2017 Year 08 Month 31 Day

Date analysis concluded

2017 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2005 Year 08 Month 29 Day

Last modified on

2020 Year 03 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000133


Research Plan
Registered date File name
2020/03/09 2017-8-8-ABC study-CVDT.pdf

Research case data specifications
Registered date File name
2020/03/09 2017-8-8-ABC study-CVDT.pdf

Research case data
Registered date File name
2020/03/09 2017-8-8-ABC study-CVDT.pdf