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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013630
Receipt No. 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

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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
Institute Hakodate cardiovascular disease round-table conference
Institute
Department

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
URL(English) https://upload.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


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