Unique ID issued by UMIN | C000000091 |
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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 |
The Japan Working Group for the Assessment That the Pioglitazone Protects DM Patients Against Re-Infarction
PPAR Study
The Japan Working Group for the Assessment That the Pioglitazone Protects DM Patients Against Re-Infarction
PPAR Study
Japan |
DM patients(HbA1c < 6.5%) with the history of myocardial infarcion
Cardiology | Endocrinology and Metabolism |
Others
NO
To evaluate whether the pioglitazone could reduce the recurrence of myocardial infarction in patients with DM and old myocardial infarction
Efficacy
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.
(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)
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
NO
NO
Institution is considered as a block.
YES
Central registration
2
Prevention
Medicine |
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.
In control group, (1)each participated doctor (1)instructs weight reduction, appropriate diet, regular exercise and/or (2)prescribes sulfonylurea agents.
20 | years-old | <= |
79 | years-old | >= |
Male and Female
1.diabetes mellitus (HbA1c < 6.5%)
2.History of myocardial infarction
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
720
1st name | Masafumi |
Middle name | |
Last name | Kitakaze |
National Cerabral and Cardiovascular Center
Cardiovascular Division
565-8565
5-7-1 Fujishirodai, Suita City, Osaka Pref. 565-8565, Japan
06-6833-5012
kitakaze@zf6.so-net.ne.jp
1st name | Masanori |
Middle name | |
Last name | Asakura |
Clinical Study Support Center Japan (CSSCJ)
PPAR office
565-8565
5-7-1 Fujishirodai, Suita City, Osaka Pref. 565-8565
06-6836-0077
http://www.csscj.com
kitakaze@zf6.so-net.ne.jp
Department of Clinical Meidicine and Development, National Cerebral and Cardiovascular Center
Japan Heart Foundation
Non profit foundation
IRB of NCVC
5-7-1- Fujishirodai Suita
06-6833-5012
matsuji@mgt.ncvc.go.jp
NO
2005 | Year | 08 | Month | 31 | Day |
https://www.ncbi.nlm.nih.gov/pubmed/31193597
Published
https://www.ncbi.nlm.nih.gov/pubmed/31193597
630
The primary endpoint was observed in 14.2% and 14.1% patients in the control and pioglitazone groups during two years.
2020 | Year | 03 | Month | 09 | Day |
2018 | Year | 10 | Month | 22 | Day |
630 patients with mild DM with a history of MI to undergo either DM therapy
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).
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.
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).
Completed
2004 | Year | 11 | Month | 01 | Day |
2005 | Year | 04 | Month | 01 | Day |
2005 | Year | 04 | Month | 01 | Day |
2014 | Year | 12 | Month | 31 | Day |
2017 | Year | 04 | Month | 30 | Day |
2017 | Year | 08 | Month | 31 | Day |
2017 | Year | 10 | Month | 31 | Day |
2005 | Year | 08 | Month | 29 | Day |
2020 | Year | 03 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000133
Research Plan | |
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Registered date | File name |
2020/03/09 | 2017-8-8-ABC study-CVDT.pdf |
Research case data specifications | |
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Registered date | File name |
2020/03/09 | 2017-8-8-ABC study-CVDT.pdf |
Research case data | |
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Registered date | File name |
2020/03/09 | 2017-8-8-ABC study-CVDT.pdf |