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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020421
Receipt No. R000023422
Scientific Title Comparison of Chronic Intra-stent Condition after Resolute Zotarolimus-Eluting Stent Implantation with Dual versus Single Antiplatelet Therapy with Prasgrel
Date of disclosure of the study information 2016/01/04
Last modified on 2018/07/07

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Basic information
Public title Comparison of Chronic Intra-stent Condition after Resolute Zotarolimus-Eluting Stent Implantation with Dual versus Single Antiplatelet Therapy with Prasgrel
Acronym Dual versus Single Antiplatelet Therapy with Prasgrel for R-ZES implantation
Scientific Title Comparison of Chronic Intra-stent Condition after Resolute Zotarolimus-Eluting Stent Implantation with Dual versus Single Antiplatelet Therapy with Prasgrel
Scientific Title:Acronym Dual versus Single Antiplatelet Therapy with Prasgrel for R-ZES implantation
Region
Japan

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

Objectives
Narrative objectives1 To evaluate noninferiority of one months DAPT following single antiplatelet therapy with Prasgrel for chronic intra-stent condition of Resolute Zotarolimus-eluting stent.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 9 months optical coherence tomography data (intra-stent thrombus, neointimal healing, etc)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 single antiplateltet therapy of Prasgurel followed by 1 month Prasgurel+aspirin dual antiplatelet therapy
Interventions/Control_2 12 months prasgrel + aspirin dual antiplatelet therapy
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patient with coronary artery disease who implanted Resolute zotarolimus-eluting stent by optical coherence tomograpy
Key exclusion criteria Acute coronary syndrome
Unprotected left main coronary artery disease
Chronich renal dysfunction
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Sawada
Organization Hyogo Prefectural Himeji Cardiovascular Center
Division name Cardiology
Zip code
Address 520, Saisho-kou, Himeji
TEL 079-293-3131
Email taktak319@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mikio Yasui
Organization Hyogo Prefectural Himeji Cardiovascular Center
Division name General Cordinaion Division
Zip code
Address 520, Saisho-kou, Himeji
TEL 079-293-3131
Homepage URL
Email mikio_yasui@pref.hyogo.lg.jp

Sponsor
Institute Hyogo Prefectural Himeji Cardiovascular Center
Institute
Department

Funding Source
Organization Hyogo Prefectural Himeji Cardiovascular Center
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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 04 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 Main results already published
Date of protocol fixation
2015 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2015 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
2016 Year 01 Month 04 Day
Last modified on
2018 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023422

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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