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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000091
Receipt No. 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

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

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
URL(English) https://upload.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


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