UMIN-CTR Clinical Trial

Public title

Warfarin versus Edoxaban for Treatment of Deep Vein Thrombosis (DVT) in Patients with Severe Motor Intellectual Disabilities (SMID)

Acronym

NHOJ-DVT

Scientific Title

Warfarin versus Edoxaban for Treatment of Deep Vein Thrombosis (DVT) in Patients with Severe Motor Intellectual Disabilities (SMID)

Scientific Title:Acronym

NHOJ-DVT

Region

Japan

Condition

Severe Motor and Intellectual Disabilities

Classification by specialty

Cardiology	Vascular surgery	Pediatrics
Laboratory medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Most patients with severe motor and intellectual disabilities (SMID) have restricted mobility capability and have been bedridden for long periods because of paralysis of the extremities caused by abnormal muscular tonicity due to cerebral palsy and developmental disabilities, and such patients thought to be associated with a high risk for the complications of deep vein thrombosis (DVT). In cross sectional study, we examine the incidence and risk factors of DVT in patients with SMID. In an open-label randomized non-inferiority study, we randomly assigned patients with DVT, who have initially received warfarin or edoxaban. As a result, we evaluate the primary safety outcome for major or clinically relevant nonmajor bleeding.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1) Cross sectional Study
Incidence of DVT,Risk factors of DVT
2) Open-label Randomaized Trial of DVT
Primary End-point
Safety Outcome during on-treatment : major or clinically relevant nonmajor bleeding

Key secondary outcomes

Thrombotic burden assessment including size, location and number of DVT on venous ultrasound
-Changes of coagulation markers
-Bleeding in routine care for SMID patients
-Incidences of adverse event for the study period
-Exploratory end point
-Frequency of measurement of PT-INR in warfarin group
-Frequency of dosage adjustments for warfarin
-Time in therapeutic INR range in warfarin group

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

YES

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Warfarin group: After diagnosis of DVT, start administration of Warfarin orally.

Interventions/Control_2

Edoxaban group: After diagnosis of DVT, start administration of Edoxaban orally.

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

1) Adult patients with SMID of Oshima's Classification grade 1-4
2) Possible patients undergoing assessment for venous sonography of lower extremities
3) Patients with agreement of legally acceptable guardian

Key exclusion criteria

1) Patients with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study.
2) Patients with calculated creatinine clearance of less than 15 ml per minute
3)Patients receiving contraindicated agents for study drugs.

Target sample size

76

Name of lead principal investigator

1st name
Middle name
Last name	Hiromitsu Ohmori

Organization

National Hospital Organization Yanai Medical Center

Division name

Pediatrics

Zip code

Address

95 Ihonosho, Yanai,Yamaguchi, 742-1352, JAPAN

TEL

0820-27-0211

Email

h-h.ohmori@sound.ocn.ne.jp

Name of contact person

1st name
Middle name
Last name	Hiromitsu Ohmori

Organization

National Hospital Organization Yanai Medical Center

Division name

Pediatrics

Zip code

Address

95 Ihonosho, Yanai,Yamaguchi, 742-1352, JAPAN

TEL

0820-27-0211

Homepage URL

Email

h-h.ohmori@sound.ocn.ne.jp

Institute

National Hospital Organization Yanai Medical Center

Institute

Department

Personal name

Organization

National Hospital Organization

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

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

11

Month

14

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

To investigate the occurrence frequency of deep vein thrombosis (DVT) by the lower extremity venous ultrasonography and the occurrence factor of DVT for children with severe physical and mental disorders, and to investigate the cause of the occurrence of warts of oral anticoagulant warfarin or novel oral anti- The purpose of this study was to evaluate the efficacy and safety of coagulant (NOAC) edoxaban tosilicate hydrate formulation (Lixiana) administered. DVT cases were randomly assigned to two groups, warfarin group and NOAC group, and the occurrence frequency of hemorrhagic events was evaluated as efficacy and the adverse event expression rate was compared as safety evaluation items. Of the 171 total registered cases, 14 cases (8.4%) were DVT cases among 167 patients except DVT unevaluated cases and ineligible cases. Factors related to the presence of DVT were age (OR = 1.09, 95% CI = 1.03 - 1.15). Regarding DVT cases, we compared the warfarin-administered group and the NOAC-administered group, 4 cases in the NOAC group, 0.067 / person-month, 0.067 / person-month for the hemorrhagic event (major bleeding + clinically significant bleeding) which is the main endpoint, the warfarin group Three cases and 0.042 / person-month were not different between the two (p = 0.5383). Regarding the contents of hemorrhagic events (major bleeding + clinically important bleeding), no major bleeding was seen, most of the bleeding accompanying the treatment such as subcutaneous bleeding due to bruises, suction of sputum and so on.

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

2016

Year

09

Month

01

Day

Date of IRB

Anticipated trial start date

2016

Year

11

Month

14

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Target population in the cross sectional study is 200 patients.

Registered date

2016

Year

11

Month

07

Day

Last modified on

2019

Year

01

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027767