UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027808
Receipt number R000031778
Scientific Title Effect of Direct Oral Anticoagulant (DOAC) in Adult Congenital Heart Disease Patients
Date of disclosure of the study information 2017/06/19
Last modified on 2020/08/13 14:48:56

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Basic information

Public title

Effect of Direct Oral Anticoagulant (DOAC) in Adult Congenital Heart Disease Patients

Acronym

ACHD-DOAC

Scientific Title

Effect of Direct Oral Anticoagulant (DOAC) in Adult Congenital Heart Disease Patients

Scientific Title:Acronym

ACHD-DOAC

Region

Japan


Condition

Condition

Adult congenital heart disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of Direct Oral Anticoagulant (DOAC) therapy compared with warfarin in adult congenital heart disease patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Thromboembolic events and major bleeding events during administration

Key secondary outcomes

The following events during administration:
1) Minor bleeding events
2) Intracardiac thrombus
3) Other adverse events accompanying anticoagulant drug therapy
4) Changing (dose or type) or stopping anticoagulant drug therapy
5) Discontinuation of follow-up
6) Death
7) Hospitalization


Base

Study type

Observational


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

1) Prior registration or planned registration in the database called the Japanese Network of Cardiovascular Departments for Adult Congenital Heart Disease (JNCVD-ACHD), which was established by the Japanese Society for Adult Congenital Heart Disease
2) Age over 20 years old at the time of registration between 1/1/2011 and 31/6/2019
3) Treatment with one of the following anticoagulant drugs: warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban

Key exclusion criteria

1) Age less than 20 years old
2) Incapable of obtaining participant consent
3) Judged to be medically ineligible by the attending physician

Target sample size

600


Research contact person

Name of lead principal investigator

1st name Masaki
Middle name
Last name Ieda

Organization

University of Tsukuba

Division name

Department of Cardiology, Faculty of Medicine

Zip code

3058575

Address

1-1-1 Tennodai, Tsukuba, Ibaraki, Japan.

TEL

029-853-3143

Email

mieda@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name Tomoko
Middle name
Last name Ishizu

Organization

University of Tsukuba

Division name

Department of Cardiology, Faculty of Medicine

Zip code

3058575

Address

1-1-1 Tennodai, Tsukuba, Ibaraki, Japan.

TEL

029-853-3143

Homepage URL


Email

tomoco@md.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

University of Tsukuba

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Tsukuba

Address

1-1-1 Tennodai, Tsukuba, Ibaraki, Japan.

Tel

029-853-3143

Email

tomoco@md.tsukuba.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 06 Month 19 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

2017 Year 06 Month 12 Day

Date of IRB

2019 Year 05 Month 09 Day

Anticipated trial start date

2017 Year 06 Month 12 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Planned study period: from 12 June 2017 until 31 March 2022


Management information

Registered date

2017 Year 06 Month 19 Day

Last modified on

2020 Year 08 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031778


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name