UMIN-CTR Clinical Trial

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

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

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

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

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Toho University Ohashi Medical Center

Institute

Department

Personal name

Organization

Daiichi Sankyo Co., LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Daiichi Sankyo Co., LTD

Name of secondary funder(s)

No

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Partially published

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

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 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.

Registered date

2017

Year

06

Month

30

Day

Last modified on

2021

Year

08

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032055