UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022695 |
|---|---|
| Receipt number | R000026158 |
| Scientific Title | 3-Month Discontinuation of Dual Antiplatelet Therapy after Ultimaster Sirolimus-Eluting Stent Implantation |
| Date of disclosure of the study information | 2016/06/10 |
| Last modified on | 2019/01/07 12:03:28 |
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Basic information
Public title
3-Month Discontinuation of Dual Antiplatelet Therapy after Ultimaster Sirolimus-Eluting Stent Implantation
Acronym
MODEL U-SES
Scientific Title
3-Month Discontinuation of Dual Antiplatelet Therapy after Ultimaster Sirolimus-Eluting Stent Implantation
Scientific Title:Acronym
MODEL U-SES
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
Dual Antiplatelet Therapy period to 3 months after implantation of Ultimaster Sirolimus-eluting stent (U-SES). Additionally to investigate appropriateness of thienopyridine monotherapy with discontinuation of aspirin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
composite endpoint of all cause death in 12 months, myocardial infarction (MI), stroke (ischemic and hemorrhagic), ARC Definite / Probable stent thrombosis and serious bleeding (BARC 3 or 5).
Key secondary outcomes
- composite endpoint of all cause death in 3 months, myocardial infarction (MI), stroke
(ischemic and hemorrhagic), ARC Definite/Probable stent thrombosis
and serious bleeding (BARC 3 or 5).
- MACE
- All cause death
- Cardiac death
- MI
- Stroke(ischemic and hemorrhagic)
- TVR
- TLR
- Readmission related to Angina
- TIA
- Stent thrombosis
-Bleeding complications (BARC definition)
- comparison of event rate by the type of antiplatelet agent
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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 aspirin or thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patients with coronary artery lesion who received PCI using U-SES.
-Patient considered appropriate to
discontinue DAPT at 3 month after stent implantation.
-Patients who have provided written informed consent
Key exclusion criteria
- Patients previously experienced stent thrombosis
- Patients who are unable to follow up
- Patients who are enrolled or planned to participate in another clinical trials of antiplatelet therapy.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Kozuma |
Organization
Teikyo University Hospital
Division name
Division of Cardiology
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL
03-3964-1211
PXE00364@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihisa Hanawa |
Organization
Meditrix Corporation
Division name
MODEL U-SES Administrative Office
Zip code
Address
1-15, Hirakawa-cho, Chiyoda-ku, Tokyo, Japan
TEL
03-6261-5111
Homepage URL
yukihisa.hanawa@meditrix.jp
Sponsor or person
Institute
Teikyo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Terumo Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2016 | Year | 06 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 27 | 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 | 06 | Month | 10 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026158
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
