UMIN-CTR Clinical Trial

Public title

Prospective study of delayed bleeding after colorectal EMR and polypectomy in patients receiving Rivaroxaban uninterruptedly before retiring

Acronym

Prospective study of delayed bleeding after colorectal EMR and polypectomy in patients receiving Rivaroxaban uninterruptedly before retiring(RUBR)

Scientific Title

Prospective study of delayed bleeding after colorectal EMR and polypectomy in patients receiving Rivaroxaban uninterruptedly before retiring

Scientific Title:Acronym

Prospective study of delayed bleeding after colorectal EMR and polypectomy in patients receiving Rivaroxaban uninterruptedly before retiring(RUBR)

Region

Japan

Condition

colorectal polyps

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

analysis of delayed bleeding after colorectal polypectomy and EMR in patients receiving Rivaroxaban uninterruptedly

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

analysis of delayed bleeding after colorectal polypectomy and EMR for 4 weeks

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Maneuver

Interventions/Control_1

Before the admission of the colorectal polypectomy about 2 weeks,patients start to take a 15mg tablet of Rivaroxaban before retiring.

Reducing criteria for 10mg Rivaroxaban
Ccr less than50ml/min
Age over75 years old
Body weight less than50kg

Patients admit into the hospital on the day before the polypectomy.
The polypectomy is done in the afternoon with uninterruputed using Rivaroxaban before retiring.
Patients start to eat after two days from the polypectomy.
If bloody stools are not occured,patients are permitted discharge.
They take Rivaroxaban before retiring for 4weeks continuously after the polypectomy,and have occurrence of bloody stools observed.

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

90

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients receiving anticoagulants with colorectal polyps under 20mm diameter

Performance status 0 or 1

WBC over3000/mm3 and under12000/mm3
Hb over9.0g/dL
Plt over100000/mm3
AST,ALT under100IU
T.Bil under2.0mg/dL
Ccr less than1.77mg/dL and Ccr over15ml/min
PT-INR under3 (less than70 years old)
PT-INR under2.6(over70 years old)

Key exclusion criteria

Contraindicated cases for taking Rivaroxaban
Patients with artifical heart valve
Patients with vasucular atrial fibrillation
Liver chirrhosis patients with type B or C in child-pugh classfication
Patients taking azole antifungal drug,the HIV-protease inhihibitors or drugs including cobicistat
Patinens contracting acute infective endocarditis
Women who are or may be pregnant
Patients taking aspirin or Thienopyridine
Dialysis patients
Patients with past history of gastrointestinal bleeding or intracranial hemorrhage

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	manabu kubota

Organization

Asahi General Hospital

Division name

Dept. of Gastroenterology

Zip code

Address

I-1326 Asahi-shi Chiba-ken JAPAN

TEL

0479-63-8111

Email

manabukuboa@hospital.asahi.chiba.jp

Name of contact person

1st name
Middle name
Last name	manabu kubota

Organization

Asahi General Hospital

Division name

Dept. of Gastroenterology

Zip code

Address

I-1326 Asahi-shi Chiba-ken JAPAN

TEL

0479-63-8111

Homepage URL

Email

manabukuboa@hospital.asahi.chiba.jp

Institute

Asahi General Hospital

Institute

Department

Personal name

Organization

Asahi General Hospital

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2016

Year

05

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2016

Year

04

Month

06

Day

Date of IRB

Anticipated trial start date

2016

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

05

Month

30

Day

Last modified on

2016

Year

11

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025879