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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027793
Receipt No. R000031850
Scientific Title Clot regression effects of rivaroxaban in treatment of venous thromboembolism in cancer patients.
Date of disclosure of the study information 2017/06/17
Last modified on 2017/06/16

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Basic information
Public title Clot regression effects of rivaroxaban in treatment of venous thromboembolism in cancer patients.
Acronym Clot regression effects of rivaroxaban in treatment of venous thromboembolism in cancer patients.
Scientific Title Clot regression effects of rivaroxaban in treatment of venous thromboembolism in cancer patients.
Scientific Title:Acronym Clot regression effects of rivaroxaban in treatment of venous thromboembolism in cancer patients.
Region
Japan

Condition
Condition Venous thromboembolism
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the clot regression effects of rivaroxaban in cancer patients who developed venous thromboembolism (VTE) such as deep vein thrombosis (DVT) or pulmonary embolism (PE).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clot regression evaluated by contrast-enhanced CT imaging (Imaging is performed at baseline, 3 weeks and 3 months days after initiation of treatment).The ratio of clot volume regression after 3 weeks or 3 months compared with the clot volume at baseline is investigated. In addition, the rate of normalization (no thrombus in legs and lungs) is also investigated.
Key secondary outcomes 1)Recurrence of symptomatic DVT or PE
2)Hemorrhagic complications
Major bleeding:Clinically definite reduction in Hb by 2.0 g/dL or more, Bleeding requiring 2 units or more of transfusion, Intracranial hemorrhage, retroperitoneal hemorrhage, and bleeding to death
Non-major bleeding: Bleeding clinically associated with rivaroxaban not meeting the criteria for major bleeding

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 VTE patients receive the NHI-covered standard rivaroxaban treatment (30 mg/day for 3 weeks after initiation of treatment, followed by 15 mg/day).
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
75 years-old >
Gender Male and Female
Key inclusion criteria Patients aged 20 to 75 years, with active cancer at diagnosis with VTE. Active cancer at baseline was defined as a diagnosis of cancer that occurred within 6 months before enrollment, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer.
Key exclusion criteria Patients contraindicated for rivaroxaban, with creatinine clearance <30 mL/min, with isolated distal DVT, within 6 months in the remaining days, with a vitamin K antagonist, with severe complication (significant liver disease, active bleeding or a high risk of bleeding contraindicating anticoagulant treatment, severe hypertension (a systolic blood pressure of more than 180 mm Hg or a diastolic blood pressure of more than 110 mm Hg)), pregnancy, and breast-feeding. Patients who the physician in charge judges are ineligible for the present study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoaki Matoba
Organization Kyoto Prefectural University of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5511
Email matoba@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohiko Nakanishi
Organization Kyoto Prefectural University of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5511
Homepage URL
Email naka-nao@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
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

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 17 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 16 Day
Last modified on
2017 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031850

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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