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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004474
Receipt No. R000005175
Scientific Title KOBE Study of Pioglitazone Effective in Preventing Restenosis after Endovascular Therapy
Date of disclosure of the study information 2010/11/01
Last modified on 2011/07/29

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Basic information
Public title KOBE Study of Pioglitazone Effective in Preventing Restenosis after Endovascular Therapy
Acronym KOBE-SPEED
Scientific Title KOBE Study of Pioglitazone Effective in Preventing Restenosis after Endovascular Therapy
Scientific Title:Acronym KOBE-SPEED
Region
Japan

Condition
Condition Femoropopliteal artery lesion area (Rutherford 1 category 4) in type 2 diabetes complicated by a chronic arteriosclerosis obliterans
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether pioglitazone suppressed the development of restenosis after endovascular treatment(EVT: Endovascular Therapy) in patients with chronic obstructive atherosclerosis in type 2 diabetes mellitus.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes After six months of treatment before and IVUS neointimal thickness by the amount of quantitative assessment.
Key secondary outcomes 1. Patency rate
2. Ankle Brachial Pressure Index (ABI)
3. Rutherford classification (1-4) Change in
4. All-cause mortality and cardiovascular events(TIA, including ischemic stroke, hemorrhagic stroke, myocardial infarction and other vascular accident)
5. Lower limb vascular event
Anputeshon (minor or major), move to bypass surgery, revascularization,
Stent thrombosis
6. Stent breakage rate
7. Angiographic restenosis
8. Angiographic Late Loss
9. Safety: edema, hypoglycemia, and others

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Pioglitazone treatment groups: pioglitazone 15mg orally once daily after breakfast.
Aiming HbA1C6.5% less than the oral hypoglycemic drug dosage may be adjusted.
If you get side effects, the physician's discretion, lose weight or stop.
Interventions/Control_2 Pioglitazone untreated group: standard care(SU drugs, Alpha-glucosidase inhibitor, Gurinido drugs, Biguanide drugs), the aim HbA1C6.5% less than the oral hypoglycemic drug dosage may be adjusted.
If you get side effects, the physician's discretion, lose weight or stop.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients diagnosed with diabetes type 2
2. Femoropopliteal artery lesion area (Rutherford 1 - 4 categories) patients having chronic obstructive atherosclerosis.
However, acute (7 days), subacute (less than one month) is to exclude patients with limb ischemia.
3. Normal proximal portion , an average diameter of the target vessel distal vessel diameter of 4-6mm blood vessels in the average visual Target.
4. Stenosis or occlusion in the superficial femoral artery angiography new , TASKII Category A or B or C corresponding to the lesion. From the deep femoral artery bifurcation lesions in the distal superficial femoral artery and more than 1cm, 3cm from the patella to target those that exist between more proximal.
5. Run-off arteries below the knee and one or more, flow limiting stenosis, if you can not. In addition, patients with lesions on both sides of a merger, the aorta - a target for patients with iliac artery disease complications. However, endovascular treatment of bilateral lesions in patients with 30 days to make the treatment of each limb at intervals of 45 days.
6. Lower extremity arterial (BK:Below knee), iliac artery (Iliac Artery) with simultaneous treatment possible.
7. A target for occlusion
Key exclusion criteria 1. Patients with Congestive Heart Failure
2. Creatinine or 2mg/dL
3. Patients on hemodialysis
4. Leukopenia drug ingredients for research hepatic dysfunction, severe side effects such as renal dysfunction,
Patients with a history of hypersensitivity
5. Patients are pregnant or potentially pregnant women
6. Subacute patients with acute limb ischemia
7. Insulin-treated patients
(Eg, insulin administration was started during the study will continue to study)
8. Patients with a history of adverse reactions to thiazolidinediones
9. Patients with severe liver dysfunction in renal function
10. The patient will be excluded from the safety of thiazolidinediones in terms of
11. In addition, at the discretion of the attending physician considered patient inappropriate for study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiro Shinke
Organization Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-5846
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshiro Shinke
Organization Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-5846
Homepage URL
Email shinke@med.kobe-u.ac.jp

Sponsor
Institute Division of Cardiovascular Medicine , Department of Internal Medicine,
Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Boston Scientific Corporation
Johnson & Johnson K.K.
Takeda Pharmaceutical Company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2010 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2010 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 28 Day
Last modified on
2011 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005175

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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