UMIN-CTR Clinical Trial

Basic information
Public title	Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event
Acronym	Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event (PENDULUM registry)
Scientific Title	Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event
Scientific Title:Acronym	Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event (PENDULUM registry)
Region	Japan

Condition
Condition	Patients with ACS or elective indications undergoing PCI with drug-eluting stent implantation.
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the incidence of thrombotic and bleeding events following treatment with antiplatelet drugs in Japanese patients undergoing PCI with drug-eluting stent implantation. To evaluate factors influencing thrombotic and bleeding events in relation to patient background, antiplatelet effect, among others, and to use the results to better inform clinical decision-making to optimize treatment options in relation to patient risk.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Efficacy: The incidence of the composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and stent thrombosis at 12 months after index PCI. Safety: The incidence of major bleeding at 12 months after index PCI. (Major bleeding: BARC type 3 or type 5)
Key secondary outcomes	The incidence of the events listed below within 1 month and 30 months after index PCI. The incidence of composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, stent thrombosis The incidence of major bleeding. The incidence of the events listed below within 1 month, 12 months and 30 months after index PCI. Bleeding event (each category according to BARC criteria; major bleeding and minor bleeding according to TIMI criteria). Major adverse clinical, cardiac or cerebral events (all-cause death, cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, nonfatal ischemic stroke, revascularization (TVR, TLR), TIA, stent thrombosis, and peripheral arterial occlusive disease)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 are included in the study if all of the following criteria are met: 1.Patients 20 years of age or older at the time of informed consent 2.Patients who have coronary lesions visually confirmed by coronary angiography and are indicated for PCI with drug eluting stent (patients would be judged by referring package insert.). 3.Patients who are treated with antiplatelet drug(s) after hospitalization to discharge to undergo PCI with drug eluting stent. 4.Patients who agreed to participate in the clinical study after being informed in detail
Key exclusion criteria	Patients are excluded from the study if the following criteria is met: Patients who are in or plan to participate in such clinical study/ research before the end of follow-up in this study.
Target sample size	5000

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	2-7-6 Ohashi, Meguro, Tokyo, Japan
TEL	03-3468-1251
Email	masato@oha.toho-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masashi Odani
Organization	CMIC Co., Ltd.
Division name	Academia Clinical Research Div.
Zip code
Address	Hamamatsucho Bldg., 1-1-1 Shibaura, Minato-ku, Tokyo, Japan
TEL	03-6779-8172
Homepage URL
Email	masashi-odani@cmic.co.jp

Sponsor
Institute	Toho University Ohashi Medical Center
Institute
Department

Funding Source
Organization	Daiichi Sankyo Co., LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Daiichi Sankyo Co., LTD
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2015 Year 12 Month 25 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	6422
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	2015 Year 11 Month 27 Day
Date of IRB	2015 Year 12 Month 14 Day
Anticipated trial start date	2015 Year 12 Month 31 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This trial is a non-randomised, prospective registry study. In principal, investigators will obtain informed consent from patients or their legally acceptable representatives before index PCI, and they will consecutively enroll patients who meet the inclusion criteria, but not the exclusion criteria.

Management information
Registered date	2015 Year 12 Month 24 Day
Last modified on	2020 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023479