Diabetes MellitusPhase 4NCT00212004
Pioglitazone Protects Diabetes Mellitus (DM) Patients Against Re-Infarction (PPAR Study)
A Phase 4 study testing pioglitazone in people with Diabetes Mellitus and Myocardial Infarction, run by National Cerebral and Cardiovascular Center, Japan at 1 site in Japan.
Trial summary
To evaluate whether the pioglitazone could reduce the recurrence of myocardial infarction (MI) in patients with DM and old myocardial infarction Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Diabetes Mellitus, Myocardial Infarction
- What is being tested?
- pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2005to Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Japan Working Group for the Assessment That the Pioglitazone Protects DM Patients Against Re-Infarction
To evaluate whether the pioglitazone could reduce the recurrence of myocardial infarction (MI) in patients with DM and old myocardial infarction
Read the detailed description
Type 2 diabetes mellitus is a well-established risk factor for coronary heart disease and atherosclerotic change in coronary artery. So we designed a prospective randomized multi-center trial named the pioglitazone could reduce the recurrence of myocardial infarction in patients with DM and myocardial infarction(PPAR study) to evaluate whether pioglitazone could reduce the recurrence of myocardial infarction in patients with DM(HbA1c<6.5%) and myocardial infarction.
More than 100 hospitals will participate in the PPAR study. Patients with DM who have history of prior myocardial infarction are randomly allocated to receive pioglitazone or (1)instructs weight reduction, appropriate diet, regular exercise and/or (2)prescribes sulfonylurea agents. The number of patients to be recruited is 720 and this study will continue at least 2 years until 7 year or the end of the study. The primary end-points are (1) cardiovascular mortality and (2) hospitalization for cardiovascular events. Effects in suppression of new diabetes development also will be evaluated.
We should recognize DM as important therapeutic target to decrease recurrence of cardiovascular events. PPAR study, a large scale multi-center trial in Japan, will provide us new evidence how to treat DM patients with prior myocardial infarction.
- Conditions
- Diabetes Mellitus, Myocardial Infarction
- Being tested
- pioglitazone, control
- Keywords
- diabetes mellitus, myocardial infarction, pioglitazone
- Medical subject headings
- Diabetes Mellitus, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazoneDrug
controlOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (7)
All cause mortality
death of any cause
Measured: 2 years
Hospitalization due to nonfatal myocardial infarction
nonfatal myocardial infarction
Measured: 2 years
Hospitalization due to nonfatal unstable angina
nonfatal unstable angina
Measured: 2 years
Hospitalization due to treatment with coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft)
coronary revascularisation
Measured: 2 years
Hospitalization due to cerebral infarction
cerebral infarction
Measured: 2 years
The progression of DM
HbA1C levels>7.0%
Measured: 2 years
worsening of renal function
serum creatine levels>2.5mg/dL or the increases of serum creatine levels by >2mg/dL
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionApr 2017
- Study completionApr 2018
Why it stopped: Limited budget to continue this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cerebral and Cardiovascular Center, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Heart Foundation
- Responsible party
- Principal investigator, Masafumi Kitakaze, National Cerebral and Cardiovascular Center, Japan
- Investigators
- Masafumi Kitakaze, MD, PhD, Study chair, National Cerebral and Cardiovascular Center, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212004
- Sponsor's protocol ID
- CSSCJ-4
- Other IDs
- UMIN_ID:C000000091, Umin Center
- Status last verified
- May 2018
- First submitted
- 13 Sep 2005
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Japan Working Group for the Assessment That the Pioglitazone Protects DM Patients Against Re-Infarction
- ClinicalTrials.gov ID
- NCT00212004
- Acronym / sponsor ID
- CSSCJ-4
- Conditions
- Diabetes Mellitus, Myocardial Infarction
- Keywords
- diabetes mellitus, myocardial infarction, pioglitazone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited budget to continue this study
- Enrolment
- 630 participants (actual)
- Lead sponsor
- National Cerebral and Cardiovascular Center, JapanUniversity, hospital or other
- Collaborators
- Japan Heart Foundation
- Study start
- Apr 2005 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate whether the pioglitazone could reduce the recurrence of myocardial infarction (MI) in patients with DM and old myocardial infarction
Detailed description
Type 2 diabetes mellitus is a well-established risk factor for coronary heart disease and atherosclerotic change in coronary artery. So we designed a prospective randomized multi-center trial named the pioglitazone could reduce the recurrence of myocardial infarction in patients with DM and myocardial infarction(PPAR study) to evaluate whether pioglitazone could reduce the recurrence of myocardial infarction in patients with DM(HbA1c<6.5%) and myocardial infarction.
More than 100 hospitals will participate in the PPAR study. Patients with DM who have history of prior myocardial infarction are randomly allocated to receive pioglitazone or (1)instructs weight reduction, appropriate diet, regular exercise and/or (2)prescribes sulfonylurea agents. The number of patients to be recruited is 720 and this study will continue at least 2 years until 7 year or the end of the study. The primary end-points are (1) cardiovascular mortality and (2) hospitalization for cardiovascular events. Effects in suppression of new diabetes development also will be evaluated.
We should recognize DM as important therapeutic target to decrease recurrence of cardiovascular events. PPAR study, a large scale multi-center trial in Japan, will provide us new evidence how to treat DM patients with prior myocardial infarction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Active comparator | Drug: pioglitazoneParticipants 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. |
| Control | Active comparator | Other: controlParticipants assigned to Control group were treated with diet and exercise therapy or sulfonylurea (SU) or other additional drugs than pioglitazone. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pioglitazone | Drug | Pioglitazone |
| control | Other | Control |
Primary outcome
The time till the first cardiovascular composite endpoint
Time frame: 2 years
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.
7 secondary outcomes
All cause mortality
Time frame: 2 years
Hospitalization due to nonfatal myocardial infarction
Time frame: 2 years
Hospitalization due to nonfatal unstable angina
Time frame: 2 years
Hospitalization due to treatment with coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft)
Time frame: 2 years
Hospitalization due to cerebral infarction
Time frame: 2 years
The progression of DM
Time frame: 2 years
worsening of renal function
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Limited budget to continue this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masafumi Kitakaze, MD, PhD study chair
National Cerebral and Cardiovascular Center, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pioglitazone in people with Diabetes Mellitus and Myocardial Infarction, run by National Cerebral and Cardiovascular Center, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Limited budget to continue this study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time till the first cardiovascular composite endpoint (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.