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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000028105
Receipt No. R000032126
Scientific Title Evaluation of rivaroxaban for distal deep vein thrombosis - a single-center, randomized, open-label, assessor-blind, parallel group, exploratory study
Date of disclosure of the study information 2017/07/06
Last modified on 2017/09/13

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Basic information
Public title Evaluation of rivaroxaban for distal deep vein thrombosis - a single-center, randomized, open-label, assessor-blind, parallel group, exploratory study
Acronym ISE calf DVT study
Scientific Title Evaluation of rivaroxaban for distal deep vein thrombosis - a single-center, randomized, open-label, assessor-blind, parallel group, exploratory study
Scientific Title:Acronym ISE calf DVT study
Region
Japan

Condition
Condition distal deep vein thrombosis
Classification by specialty
Cardiology Vascular surgery Cardiovascular surgery
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to investigate the usefulness of anticoagulant treatment with rivaroxaban in patients with newly diagnosed distal deep vein thrombosis (DVT), who has a risk of thrombus extension.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Composite endpoint of asymptomatic proximal DVT, symptomatic proximal DVT, symptomatic non-fatal PE or fatal PE, within 90 days after starting the study
Key secondary outcomes 1) Occurrences of recurrent distal DVT within 90 days after starting the study
2) Occurrences of symptomatic proximal DVT within 90 days after starting the study
3) Occurrences of asymptomatic proximal DVT within 90 days after starting the study
4) Occurrences of symptomatic pulmonary embolism (PE) (fatal or non-fatal) within 90 days after starting the study
5) Composite of 1) -4)
6) Occurrences of recurrent distal DVT within 120, 180, and 365 days after starting the study
7) Occurrences of symptomatic proximal DVT within 120, 180, and 365 days after starting the study
8) Occurrences of asymptomatic proximal DVT within 120, 180, and 365 days after starting the study
9) Occurrences of symptomatic PE (fatal or non-fatal) within 120, 180, and 365 days after starting the study
10) Composite of 6) -9)
11) Composite of 7) -9)
12) Change in thrombus volume in 8, 21, and 90 days after starting the study
13) Biomarkers related to fibrinolytic and coagulation system (D dimer, SF)
14) Occurrences of *clinically relevant bleeding events within 90, 120, 180, and 365 days after starting the study
*clinically relevant bleeding events: composite endpoint of major bleeding events or other clinically relevant non-major bleeding events
15) Composite of asymptomatic proximal DVT, symptomatic proximal DVT, symptomatic PE (fatal or non-fatal), or clinically relevant bleeding events within 90, 120, 180, and 365 days after starting the study
16) Composite of asymptomatic proximal DVT, symptomatic proximal DVT, symptomatic PE (fatal or non-fatal), or major bleeding events within 90, 120, 180, and 365 days after starting the study

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Rivaroxaban and physical treatment group
Rivaroxaban 15 mg tablets shall be orally administered after meal twice daily for 21 days after starting treatment (initial treatment period).Subsequently, the dosage shall be reduced to 15 mg tablet once daily for 69 days(maintenance period).If a bleeding risk is concerned in the initial treatment period, the dosage can be reduced to 15 mg tablet once daily according to the judgment by the physician.
In addition, the physical therapy including wearing an elastic stocking or an elastic wrap shall be thoroughly instructed.
Interventions/Control_2 Physical treatment group
The physical therapy including wearing an elastic stocking or an elastic wrap shall be thoroughly instructed.
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 Male and female patients who have been newly diagnosed with distal DVT by CUS shall meet the following criteria:
(1) Male and female patients whose age is 20 years or older.
(2) A written consent has been obtained
(3) Patients who have at least one of the following risks for extending distal DVT which are listed in the 9th edition of ACCP guidelines:
a) Associated with swelling/pain
b) D-dimer positive
c) Thrombosis that is extensive, or close to the popliteal veins
d) Having an active malignant disease
e) Having a medical history of proximal DVT or PE
f) Being hospitalized
g) Idiopathic
Key exclusion criteria 1) A patient who was allocated in this study previously
2) A patient who has already started an anticoagulant treatment including preventive medications for postoperative DVT at the orthopedic department etc.
3) A patient who has other diseases than DVT, which anticoagulants are indicated for
4) A patient who is not applicable for wearing an elastic stocking or an elastic wrap
5) A patient who has a medical history of hypersensitivity against rivaroxaban
6) A patient who has severe renal impairment [estimated creatinine clearance (CLCR) <30 ml/min: calculated from Cockcroft-Gault formula]
7) A patient with active bleeding
8) A patient who has hepatic impairment of Child-Pugh classification B and C
9) A pregnant or potentially pregnant female or a nursing female
*Pregnancy shall be checked by hearing consultation. Even with a slight suspicion, the patient shall be excluded.
10) A patient who has been on a HIV protease inhibitor*
11) A patient who has been on a Cobicistat-containing product*
12) A patient who has been on an oral or injectable azole antifungal drug*
13) A patient who is suffering acute bacterial endocarditis
14) A patient who received a CNS surgery recently or has a cerebral hemorrhage which developed recently
15) A patient who has acute symptomatic PE, or acute proximal DVT with or without symptoms
16) A patient who has serious complications, of which life prognosis is considered to be <3 months
17) A patient who has uncontrolled hypertension (systolic pressure >180 mmHg or diastolic pressure >110 mmHg)
18) A patient who has participated in any clinical trials of other drugs or medical devices within 30 days prior to randomization
19) A patient who is not able to comply with series of processes related to the clinical study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Ito
Organization Mie University Graduate School of Medicine
Division name Department of Cardiology and Nephrology
Zip code
Address 2-174, Edobashi, Tsu, Mie
TEL 059-231-5015
Email mitoka@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshito Ogihara
Organization Mie University Graduate School of Medicine
Division name Department of Cardiology and Nephrology
Zip code
Address 2-174, Edobashi, Tsu, Mie
TEL 059-231-5015
Homepage URL
Email yoshito@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University Graduate School of Medicine
Department of Cardiology and Nephrology
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd
Organization
Division
Category of Funding Organization Profit organization
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 三重大学医学部附属病院(三重県)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 06 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 Terminated
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 02 Day
Last follow-up date
2019 Year 07 Month 31 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 07 Month 06 Day
Last modified on
2017 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032126

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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