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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006698
Receipt No. 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

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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
Email 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
Email info@nippon-trial.org

Sponsor
Institute NPO Associations for Establishment of Evidence in Interventions
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007918

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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