UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039418
Receipt number R000044714
Scientific Title MAnagement of Direct Oral anticoagulant (DOACs) While Peripolypectomy Period: randomized A randomized controlled, mUlticenter trial
Date of disclosure of the study information 2020/02/08
Last modified on 2020/02/19 02:14:09

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Basic information

Public title

A randomized controlled, multicenter trial investigating management of Direct Oral anticoagulant (DOACs) for colorectal polypectomy

Acronym

A randomized controlled trial on management of DOACs.

Scientific Title

MAnagement of Direct Oral anticoagulant (DOACs) While Peripolypectomy Period: randomized A randomized controlled, mUlticenter trial

Scientific Title:Acronym

A randomized controlled trial on management of DOACs.

Region

Japan


Condition

Condition

Colorectal polyp

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine the optimal administration period of Direct Oral Anticoagulants (DOACs) during the perioperative period of colon polypectomy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Rate of severe bleeding (uncontrolled intraoperative and postoperative bleeding) associated with polypectomy.

Key secondary outcomes

Rate of postoperative bleeding without emergency endoscopic hemostasis after polypectomy
Rate of bleeding requiring blood cessation immediately after polypectomy
DOAC dose intensity ( dose intensity)
The rate of bleeding in patients who underwent only Cold Snare / Forceps Polypectomy
The rate of bleeding by the type of DOAC, the rate of adverse events (the rate of thromboembolism, Incidence).


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Group to discontinuing DOACs for 1 day before lower endoscopy

Interventions/Control_2

Group to discontinue DOACs for 1 day after endoscopic resection

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 Person > 20 , < 80 years old
2 Patients taking direct oral anticoagulants (DOACs)
3 Appropriate informed consent.
4 PS, 0 or 1.
5 Blood test data
Platelet count > 100,000
Serum creatinine < 2.0mg / dl
PT% > 40%
6 Follow up of 30 days after treatment.

Note: Registration is possible even in cases after colorectal surgery.

Key exclusion criteria

1 Person who has registered in this test.
2 Inflammatory bowel disease, colon polyposis.
3 Patients are receiving systemic steroids, antiplatelet drugs, and multiple anticoagulants continuously. (However, patients who can respond to antiplatelet drugs according to the guidelines of the Japanese Endoscopy Society can be registered.)
4 Blood coagulation dysfunction disease.
5 Women who are pregnant, may become pregnant, or are breastfeeding.
6 Patients with psychosis or psychiatric symptoms seem to have difficulty participating in the study.
7 Active bacterial and fungal infection (has a fever of 38.5 degrees or higher and is associated with bacterial infectivity by diagnostic imaging or bacteriological examination).
8 Uncontrolled hypertension.
9 Respiratory disease requiring continuous oxygen administration.
10 Dialysis.
11 Others who are judged inappropriate by the attending physician (eg, the prescribing physician of the anticoagulant determined that participation in this study was dangerous).

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Yoji
Middle name
Last name Takeuchi

Organization

Osaka International Cancer Institute

Division name

Department of Gastrointestinal Oncology

Zip code

541-8567

Address

Chuoku

TEL

0669451181

Email

yoji.endoscopy@oici.jp


Public contact

Name of contact person

1st name Mitsuhiro
Middle name
Last name Kono

Organization

Osaka International Cancer Institute

Division name

Department of Gastrointestinal Oncology

Zip code

541-8567

Address

Chuoku

TEL

0669451181

Homepage URL


Email

bokuri.1229@gmail.com


Sponsor or person

Institute

Osaka International Cancer Institute

Institute

Department

Personal name



Funding Source

Organization

Japan Gastroenterological Association

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Madowazu investigators

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical research support

Address

3-1-69 Otemae, Chuo-ku, Osaka

Tel

0669451181

Email

rinri01@opho.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

2020 Year 02 Month 08 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

Enrolling by invitation

Date of protocol fixation

2019 Year 10 Month 31 Day

Date of IRB

2019 Year 12 Month 25 Day

Anticipated trial start date

2020 Year 03 Month 01 Day

Last follow-up date

2023 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 02 Month 06 Day

Last modified on

2020 Year 02 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044714


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2023/03/31 MADOWAZU trial_UMIN用シート別(医師名、識別番号、イニシャル、生年月日無し)20230322.xlsx