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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008878
Receipt No. R000009946
Scientific Title ShorT and OPtimal duration of Dual AntiPlatelet Therapy study
Date of disclosure of the study information 2012/09/15
Last modified on 2015/09/07

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Basic information
Public title ShorT and OPtimal duration of Dual AntiPlatelet Therapy study
Acronym STOPDAPT
Scientific Title ShorT and OPtimal duration of Dual AntiPlatelet Therapy study
Scientific Title:Acronym STOPDAPT
Region
Japan

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

Objectives
Narrative objectives1 To evaluate safety of reduction of thienopyridine treatment period to 3 months after implantation of Cobalt-Chromium everolimus-eluting Stents.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes composite endpoint of cardiovascular death in 12 months, myocardial infarction (MI), stroke (ischemic and hemorrhagic), stent thrombosis (Definite stent thrombosis [ST] not resulting in MI) and serious bleeding (TIMI Major/Minor).
Key secondary outcomes [major secondary endpoint]
Cardiovascular death/ MI/ stroke/ definite ST
Major bleeding (TIMI Major/ Minor)
[secondary endpoint]
Death / MI
Death
Cardiovascular death/ MI
Cardiovascular death
MI
Stroke
ST (ARC definition)
TLF
TVF
MACE
Any TLR
Clinically-driven TLR
Non-TLR
CABG
Any TVR
Any revascularization
Bleeding complications

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 discontinuation of Thienopyridine at 3moths after stent implantation
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 who received PCI using everolimus-eluting cobalt-chromium stent (Xience Prime)
Key exclusion criteria Patients who have been implanted drug eluting stent other than everolimus-eluting cobalt-chromium stent.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kimura
Organization Kyoto University Hospital
Division name Department of cardiovascular medicine
Zip code
Address 54 Shogoin-kawaramachi, sakyo-ku, kyoto 606-8507 JAPAN
TEL 075-751-4255
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Natsuaki
Organization Kyoto University Hospital
Division name Department of cardiovascular medicine
Zip code
Address
TEL 075-751-4255
Homepage URL
Email

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Abbott Vascular Japan, Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2012 Year 09 Month 15 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 Completed
Date of protocol fixation
2012 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 15 Day
Last follow-up date
Date of closure to data entry
2014 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded
2014 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2012 Year 09 Month 07 Day
Last modified on
2015 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009946

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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