UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006698 |
|---|---|
| Receipt number | R000007918 |
| Scientific Title | NoborI dual antiplatelet therapy as aPPropriate duratiON (NIPPON) |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2017/05/15 14:26:17 |
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Basic information
Public title
NoborI dual antiplatelet therapy as aPPropriate duratiON (NIPPON)
Acronym
NoborI dual antiplatelet therapy as aPPropriate duratiON (NIPPON)
Scientific Title
NoborI dual antiplatelet therapy as aPPropriate duratiON (NIPPON)
Scientific Title:Acronym
NoborI dual antiplatelet therapy as aPPropriate duratiON (NIPPON)
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the optimal duration of dual antiplatelet therapy (DAPT) after stenting with Nobori Biolimus-A9 eluting stent.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of net adverse clinical and cerebral events (NACCE) at clinical FU between 6 to 18 month after stenting.
NACCE:
NACCE is defined as a composite endpoint consisting of death from some causes (including cardiac death and noncardiac death), MI (including Q-wave MI and non-Q-wave MI), CVA, and major bleeding (as per the definitions listed in the revised version of REPLACE-2, GUSTO and BARC).
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
6 months DAPT: DAPT consisting of aspirin and thienopyridine will be discontinued at 6 months after PCI.
Interventions/Control_2
18 months DAPT: DAPT consisting of aspirin and thienopyridine will be continued for 18 months after PCI.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patient between 20 and 80 years.
2. Patient who is clinically indicated for PCI.
3. Patient who has agreed to undergo all clinical FUs listed in the present protocol.
4. Patients who can receive antiplatelet agents for 6 months after stenting.
5. Patient who has agreed to conditions after receiving an explanation about the contents of the present clinical study and who has signed the consent.
Key exclusion criteria
1. Patient with cardiogenic shock.
2. Patient who needs continuous treatment of thienopyridine.
3. Patient with a history of stent thrombosis.
4. Patient who is confirmed to have an allergy or hypersensitivity to sirolimus or substance with a structure similar to biolims-A9 (ex., tacrolimus, everolimus).
5. Patient who is confirmed to have an allergy or not to have a tolerability to antiplatelet agents, anticoagulants or a contrast medium.
6. Patient who is confirmed to have an allergy or hypersensitivity to materials of Nobori biolims A-9 eluting stent.
7. Patient with a hemorrhagic predisposition or a history of coagulation abnormality.
8. Patient whose left ventricular ejection fraction (LVEF) is < 30%.
9. Patient under pregnancy (present, suspected or planned).
10. Patient who has a life expectancy of less than 12 months.
11. Patient who has an active bleeding.
12. Patient who is scheduled to undergo treatment requiring discontinuation of an antiplatelet agent.
13. Patient with a verified history of cerebral apoplexy or intracranial bleeding within 6 months before stenting.
14. Patient who is scheduled to undergo stent treatment in other lesions after the 30th day of the registration.
15. Patient who is received the follow-up observation.
16. Patient who has unprotected LMT lesion (50%>%DS).
17. Patients disqualified from participation by the investigator/sub-investigator.
18. Patient who underwent stent treatment with DES 6 months prior to the conduct of index PCI.
19. Lesions located within the saphenous venin graft (SVG).
20. Lesions with an anatomical structure of the coronary artery that is not eligible for treatment by the deployment of Nobori biolimus-A9 stent.
21. Lesions of in-stent restenosis in previously deployed DES.
Target sample size
4598
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nakamura |
Organization
Toho University Ohashi Medical Center
Division name
Division of Cardiovascular Medicine
Zip code
Address
2-17-6, Ohashi Meguro-ku, Tokyo 153-8515
TEL
+81-3-3468-1251
masato@oha.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruhisa Kiguchi |
Organization
NPO Associations for Establishment of Evidence in Interventions
Division name
NIPPON Trial support center
Zip code
Address
New Hamamatsucho Building 6F, 2-5-3 Hamamatsucho, Minato-ku, Tokyo 105-0013
TEL
03-5408-6430
Homepage URL
info@nippon-trial.org
Sponsor or person
Institute
NPO Associations for Establishment of Evidence in Interventions
Institute
Department
Personal name
Funding Source
Organization
NPO Associations for Establishment of Evidence in Interventions
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
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01514227
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 01 | 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
| 2011 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 20 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 10 | Day |
Last modified on
| 2017 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007918
