UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Quantitative Volumetric Comparison of Pulmonary Thrombus Reduction between Direct Oral Anticoagulant and Vitamin K Antagonist Treatment in Acute Phase of Symptomatic Patients
Title of the study (Brief title)	Volumetric Comparison of Pulmonary Thrombus Reduction between DOAC and VKA Treatment
Region	Japan

Condition
Condition	Pulmonary thromboembolism
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To directly compare the efficacy of thrombus volume reduction in pulmonary embolism between edoxaban and warfarin
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Reduction rate of pulmonary thrombus
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Symptomatic patients with pulmonary thromboembolism who were hospitalized in a single cardiovascular institute between February 2015 and December 2016.
Key exclusion criteria	1. Patients with unstable hemodynamics with massive thromboembolism. 2. Patients with active bleeding. 3. Patients with plenty of deep vein thrombus who needed thrombolytic therapy.
Target sample size	38

Research contact person
Name of lead principal investigator	Nobuhisa Hagiwara
Organization	Tokyo Women's Medical University
Division name	Cardiology
Address	8-1 Kawawacho, Shinjuku-ku, Tokyo
TEL	+81333538111
Email	mhagi@hij.twmu.ac.jp

Public contact
Name of contact person	Kentaro Jujo
Organization	Tokyo Women's Medical University
Division name	Cardiology
Address	8-1 Kawawacho, Shinjuku-ku, Tokyo
TEL	+81333538111
Homepage URL
Email	juken1123@mac.com

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 05 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 10 Day
Anticipated trial start date	2015 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	No significant difference in the primary endpoint between the 2 groups.

Management information
Registered date	2017 Year 05 Month 15 Day
Last modified on	2017 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031232