UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	NoborI dual antiplatelet therapy as aPPropriate duratiON (NIPPON)
Title of the study (Brief title)	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	Masato Nakamura
Organization	Toho University Ohashi Medical Center
Division name	Division of Cardiovascular Medicine
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	Teruhisa Kiguchi
Organization	NPO Associations for Establishment of Evidence in Interventions
Division name	NIPPON Trial support center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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