UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013630
Receipt number R000015909
Scientific Title Prospective study of treatment for elderly patients with PAD (peripheral arterial disease) using Propensity Score Analysis
Date of disclosure of the study information 2014/05/01
Last modified on 2014/04/04 13:39:33

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Basic information

Public title

Prospective study of treatment for elderly patients with PAD (peripheral arterial disease) using Propensity Score Analysis

Acronym

Prospective study about treatment for elderly patients with PAD (peripheral arterial disease)

Scientific Title

Prospective study of treatment for elderly patients with PAD (peripheral arterial disease) using Propensity Score Analysis

Scientific Title:Acronym

Prospective study about treatment for elderly patients with PAD (peripheral arterial disease)

Region

Japan


Condition

Condition

peripheral arterial disease

Classification by specialty

Cardiology Vascular surgery Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verify that the event risk of elderly PAD(peripheral arterial disease) patients group administered antiplatelet agent is significantly lower than that of non-administration group

Verify that stains are effective in the treatment for elderly patients with PAD(peripheral arterial disease)

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Vascular events
Death(All-cause)

Key secondary outcomes

Major bleeding
Cancer death


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

70 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

70 Years of age older

Key exclusion criteria

Patients unable to enforce the ABI test

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeo Nakajima

Organization

Nakajima Cardiovascular Medicine Mental Clinic

Division name

The director

Zip code


Address

19-13,Omoricho,Hakodate-shi,Hokkaido,040-0034,Japan

TEL

0138-22-4357

Email

shigshig@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Kazuya Yonezawa

Organization

National Hospital Organaization Hakodate National Hospital

Division name

Department of Cardiology

Zip code


Address

18-16,Kawaharacho,Hakodate-shi,Hokkaido,041-8512,Japan

TEL

0138-51-6281

Homepage URL


Email

kyonezaw@hnh.hosp.go.jp


Sponsor or person

Institute

Hakodate cardiovascular disease round-table conference

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

中島内科循環器科メンタルクリニック(北海道)


Other administrative information

Date of disclosure of the study information

2014 Year 05 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

2014 Year 02 Month 19 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 01 Day

Last follow-up date

2017 Year 05 Month 01 Day

Date of closure to data entry

2017 Year 06 Month 01 Day

Date trial data considered complete

2017 Year 06 Month 01 Day

Date analysis concluded

2017 Year 06 Month 01 Day


Other

Other related information

In order to improve the outcome


Management information

Registered date

2014 Year 04 Month 04 Day

Last modified on

2014 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015909


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name