UMIN-CTR Clinical Trial

Public title

Direct Oral Anticoagulants for Treatment and Prevention of Venous Thromboembolism in Asian Patients: A Systemic Review and Meta-analysis

Acronym

DOAC for VTE in Asian patients

Scientific Title

Direct Oral Anticoagulants for Treatment and Prevention of Venous Thromboembolism in Asian Patients: A Systemic Review and Meta-analysis

Scientific Title:Acronym

DOAC for VTE in Asian patients

Region

Japan	Asia(except Japan)	North America
South America	Australia	Europe
Africa

Condition

Venous thromboembolism pulmonary embolism deep vein thrombosis

Classification by specialty

Medicine in general	Cardiology	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To address the relationship between ethnicity and DOACs, we performed a meta-analysis assessing the differences in the efficacy and safety of DOACs in Asian patients compared with non-Asian patients, which have not been addressed in previous meta-analyses.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The efficacy was recurrent VTE or VTE-related death. The safety was major bleedings or clinically relevant non-major bleedings.

Key secondary outcomes

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Studies were considered potentially eligible for the current systematic review if they met the following pre-determined criteria: (1) they were RCTs involved more than 100 patients over 18 years of age; (2) fixed dose of DOACs were compared with therapeutic doses of VKA for the treatment and prevention of acute VTE; (3) they reported both the efficacy and safety in Asian patients.

Key exclusion criteria

-

Target sample size

27032

Name of lead principal investigator

1st name
Middle name
Last name	Yugo Yamashita

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Cardiovascular Medicine

Zip code

Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507 Japan

TEL

075-751-3111

Email

yyamashi@kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yugo Yamashita

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Cardiovascular Medicine

Zip code

Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507 Japan

TEL

075-751-3111

Homepage URL

Email

yyamashi@kuhp.kyoto-u.ac.jp

Institute

Graduate School of Medicine, Kyoto University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

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

2017

Year

11

Month

14

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/29655001

Number of participants that the trial has enrolled

Results

RESULTS: We identified 6 studies that comprised 3542 Asian and 23,481 non-Asian patients. The efficacy of DOACs was comparable with VKA in both Asian and non-Asian patients (OR, 0.90; 95% CI, 0.55-1.49; P？=？0.69 for Asian patients; OR, 0.92; 95% CI, 0.78-1.08; P？=？0.32 for non-Asian patients; P interaction？=？0.94). DOACs significantly reduced the safety endpoint compared with VKA in Asian patients (OR, 0.64; 95% CI, 0.51-0.80; P？<？0.001), while DOACs were associated with non-significant reduction in non-Asian patients (OR, 0.73; 95% CI, 0.53-1.01; P？=？0.06), indicating that the reduction seemed numerically more prominent in Asian patients, although there was no statistically significant interaction (P interaction？=？0.49).

CONCLUSIONS: The efficacy of DOACs was comparable with VKA irrespective of ethnicity, and DOACs could be safer alternatives in Asian patients.

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

Main results already published

Date of protocol fixation

2017

Year

07

Month

01

Day

Date of IRB

Anticipated trial start date

2017

Year

07

Month

01

Day

Last follow-up date

2017

Year

07

Month

01

Day

Date of closure to data entry

2017

Year

07

Month

01

Day

Date trial data considered complete

2017

Year

07

Month

01

Day

Date analysis concluded

2017

Year

08

Month

01

Day

Other related information

We performed a meta-analysis of randomized controlled trials to evaluate the efficacy and safety of DOACs in Asian and non-Asian patients with acute VTE. We searched MEDLINE, CENTRAL, and ClinicalTrials.gov through July, 2017. The efficacy was recurrent VTE or VTE-related death. The safety was major bleedings or clinically relevant non-major bleedings. The pooled odds ratios (OR) and 95% confidence intervals (CI) were calculated by a random effects model.

Registered date

2017

Year

11

Month

14

Day

Last modified on

2018

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034225