UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004474
Receipt number 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 17:51:32

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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