UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020421
Receipt number 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 09:30:24

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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 or person

Institute

Hyogo Prefectural Himeji Cardiovascular Center

Institute

Department

Personal name



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

Value
https://center6.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