UMIN-CTR Clinical Trial

Basic information
Public title	A pilot study investigating the effects of apixaban in patients with chronic disseminated intravascular coagulation (DIC)
Acronym	Apixaban in chronic DIC
Scientific Title	A pilot study investigating the effects of apixaban in patients with chronic disseminated intravascular coagulation (DIC)
Scientific Title:Acronym	Apixaban in chronic DIC
Region	Japan

Condition
Condition	Chronic Disseminated Intravascular Coagulation(Chronic DIC)
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to show that apixaban can improve the symptoms of DIC and DIC score, and be safe for patients with chronic DIC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of DIC score
Key secondary outcomes	Adverse event with apixaban (bleeding etc) Drug compliance

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Apixaban is administered
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 Patients with a diagnosis of DIC on the basis of criteria established by the DIC research group of the Ministry of Health and Welfare of Japan (1988 Revision) 2 Patients with any symptom by DIC
Key exclusion criteria	1 Patients with a history or present illness of severe allergy to a drug 2 Patients with severe renal disorder (< CLcr 30mL/min) 3 Patients whom the study drug might induce to bleed 4 Patients believed to die early even if they recovered from DIC, making it difficult to ensure a sufficient period of administration of the study drug and to obtain data on the efficacy and safety 5 Pregnant women, nursing mothers or possibly pregnant women 6 Patients whom the investigator considers to be unsuitable for participation in the study 7 Patients with severe hepatic disorder (< CLcr 30mL/min) 8 Patients with administration of other anticoagulants
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takayuki Nakayama
Organization	Aichi Medical University Hospital
Division name	Division of Hematology
Zip code
Address	1, 1, Karimata, Yazako, Nagakute, Aichi
TEL	0561-62-3311
Email	tnaka@aichi-med-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shohei Mizuno
Organization	Aichi Medical University Hospital
Division name	Division of Hematology
Zip code
Address	1, 1, Karimata, Yazako, Nagakute, Aichi
TEL	0561-62-3311
Homepage URL
Email	shohei@aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University Hospital
Institute
Department

Funding Source
Organization	Aichi Medical University Hospital
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
Address
Tel
Email

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 23 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	Completed
Date of protocol fixation	2017 Year 05 Month 11 Day
Date of IRB	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 05 Month 12 Day
Last follow-up date	2021 Year 01 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 23 Day
Last modified on	2022 Year 06 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031470