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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040985
Receipt No. R000046796
Scientific Title Oral Anticoagulation Monotherapy After Endovascular Therapy for Peripheral Artery Disease in Patients Requiring Anticoagulation
Date of disclosure of the study information 2020/09/01
Last modified on 2020/07/02

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Basic information
Public title Oral Anticoagulation Monotherapy After Endovascular Therapy for Peripheral Artery Disease in Patients Requiring Anticoagulation
Acronym Oral Anticoagulation Monotherapy After Endovascular Therapy for Peripheral Artery Disease in Patients Requiring Anticoagulation
Scientific Title Oral Anticoagulation Monotherapy After Endovascular Therapy for Peripheral Artery Disease in Patients Requiring Anticoagulation
Scientific Title:Acronym Oral Anticoagulation Monotherapy After Endovascular Therapy for Peripheral Artery Disease in Patients Requiring Anticoagulation
Region
Japan

Condition
Condition Peripheral artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of oral anti coagulate monotherapy after endovascular therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patency at 1-year
Key secondary outcomes Thrombosis
Restenosis
Target lesion revascularization
Bleeding events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral anticoagulate monotherapy
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with peripheral artery disease undergoing endovascular therapy
Patients requiring anticoagulate therapy
Key exclusion criteria intolerance for anticoagulate therapy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Masaharu
Middle name
Last name ishihara
Organization Hyogo College of Medicine
Division name Cardiovascular and renal disease medicine
Zip code 663-8131
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6553
Email hpxkg043@ybb.ne.jp

Public contact
Name of contact person
1st name Kojiro
Middle name
Last name Miki
Organization Hyogo College of Medicine
Division name Cardiovascular and renal disease medicine
Zip code 663-8131
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6553
Homepage URL
Email hpxkg043@ybb.ne.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization IRB Hyogo College of Medicine
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
Tel 0798-45-6066
Email rinri@hyo-med.ac.jp

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
2020 Year 09 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
2020 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 02 Day
Last modified on
2020 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046796

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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