UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008878 |
|---|---|
| Receipt number | 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 21:13:59 |
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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
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
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009946
