UMIN-CTR Clinical Trial

Basic information
Public title	PrasugrEl moNotherapy after DrUg eLUting stent deployMent as a Management Of patients who are uNsuitable for lOng-term dual antiplatelet therapy
Acronym	PENDULUM mono
Scientific Title	PrasugrEl moNotherapy after DrUg eLUting stent deployMent as a Management Of patients who are uNsuitable for lOng-term dual antiplatelet therapy
Scientific Title:Acronym	PENDULUM mono
Region	Japan

Condition
Condition	Patient who underwent placement of a drug elution stent by percutaneous coronary intervention, have a high bleeding risk, and are considered to have a medical difficulty in receiving long-term administration of Aspirin
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the incidence of bleeding events and cardiovascular events in patients receiving Prasugrel monotherapy without concomitant Aspirin after percutaneous coronary intervention (PCI) with implantation of a DES, who have high risk of bleeding, and who is not medically preferable to administrate Aspirin concomitantly for long-term.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence of BARC type 2, 3, and 5 bleeding events from Month 1 to 12 after index PCI.
Key secondary outcomes	To examine the incidence of events in the following A and B from Month 1 to 12 after index PCI. A. Bleeding events (each category in accordance with the BARC criteria, major bleeding and minor bleeding in the TIMI criteria) B. Cardiovascular events (all-cause death, cardiovascular death, non-lethal myocardial infarction, non-lethal stroke, non-lethal cerebral infarction, revascularization (TVR, TLR), transient ischemic attack (TIA), stent thrombosis, and peripheral artery occlusion) To examine the primary outcome (Bleeding in BARC 2,3 and 5 criteria) and secondary outcomes described above during the following evaluation periods in 1 to 3. <Evaluation period> 1. From 1 month to 24 months after PCI 2. During 12 months after PCI 3. During 24 months after PCI

Base
Study type	Others,meta-analysis etc

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 this 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 are indicated for PCI with drug eluting stent (Patients would be judged by referring product-package insert.) 3. Patients who are planned to be treated with prasugrel more than 12 months after PCI with drug eluting stent 4. Patients who satisfy at least one of the followings, and who is not medically preferable to administrate Aspirin concomitantly for long-term. (1) Complication of peptic ulcer (2) Having a history of bleeding (e.g., intracranial hemorrhage such as cerebral hemorrhage, pulmonary hemorrhage, gastrointestinal hemorrhage, ocular fundus bleeding) (3) Having a bleeding tendency (e.g., concurrent anemia, a hemoglobin level of less than 11 g/dL before PCI) (4) Having renal impairment (e.g., concurrent renal failure, dialysis, eGFR of less than 60 before PCI) (5)Continuous administration of nonsteroidal anti-inflammatory agents (NSAIDs) (other than Aspirin) after PCI is required (6)Continuous administration of oral anticoagulants (OACs) after PCI is required (7)Elderly (at least 75 years old when informed consent is obtained) (8) low body weight (<50kg) (9)Other patients who are considered to have a bleeding risk (Reason must be specified.) 5. Patients who have provided written consent to participate in the study (When emergency, patients would be asked to agree to participate in clinical study after their agent has agreed to do so.)
Key exclusion criteria	Patients are excluded from the study if any one of the following criteria is met: 1. Patients who requires dual antiplatelet therapy (DAPT) for at least 6 months from the viewpoint of a thrombotic risk 2. Bleeding patients (e.g., hemophilia, intracranial hemorrhage, gastrointestinal hemorrhage, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage) 3. Patients who underwent PCI in coronary artery bypass graft as the target lesion(s) 4. Patients who are participating or plan to participate in a clinical study or clinical research requiring intervention for the choice of antiplatelet therapy before the end of follow-up in this study 5. Patients who are participating in the clinical study titled: Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event (PENDULUM registry, UMIN000020332)
Target sample size	1100

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name Nakamura
Organization	Toho University Ohashi Medical Center
Division name	Division of Cardiovascular Medicine
Zip code	153-8515
Address	2-17-6 Ohashi, Meguro, Tokyo, Japan
TEL	03-3468-1251
Email	masato@oha.toho-u.ac.jp

Public contact
Name of contact person	1st name Hideyuki Middle name Last name Takeuchi
Organization	CMIC Co., Ltd.
Division name	Clinical Operation 3rd Div.
Zip code	105-0023
Address	Hamamatsucho Bldg., 1-1-1 Shibaura, Minato-ku, Tokyo, Japan
TEL	03-6779-8172
Homepage URL
Email	eft-mono_cta@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)	No

IRB Contact (For public release)
Organization	Toho University Ohashi Ethical Committee
Address	2-17-6 Ohashi, Meguro, Tokyo, Japan
Tel	03-3468-1251
Email	secretary@oha.toho-u.ac.jp.

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	2017 Year 07 Month 01 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	1222
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	2017 Year 05 Month 19 Day
Date of IRB	2017 Year 05 Month 31 Day
Anticipated trial start date	2017 Year 07 Month 25 Day
Last follow-up date	2020 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-randomized, 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	2017 Year 06 Month 30 Day
Last modified on	2021 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032055