NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041190009

Registered date:10/04/2019

Evaluation of Rivaroxaban for Isolated Calf Deep Vein Thrombosis

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedisolated calf deep vein thrombosis
Date of first enrollment10/04/2019
Target sample size150
Countries of recruitment
Study typeInterventional
Intervention(s)Arm (1) oral administration with rivaroxaban + physical treatment Arm (2) physical treatment

Outcome(s)

Primary OutcomeComposite end point of occurrence of symptomatic or asymptomatic proximal deep vein thrombosis and, symptomatic non-fatal or fatal pulmonary embolism
Secondary OutcomeEfficacy and safety, such as occurrence of any kinds of venous thromboembolism, change in thrombus volume, or occurrence of bleeding events

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaMale and female patients who have been newly diagnosed with isolated calf deep vein thrombosis (DVT) by lower limbs venous ultrasonography shall meet the following criteria: (1) Male and female patients whose age is 20 years or more (2) 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)Thrombosis that is extensive, or close to the popliteal veins c) Having an active malignant disease d) Having a medical history of proximal DVT or pulmonary embolism e) Being hospitalized and requiring bed rest for more than 72 hours.
Exclude criteria(1) Having already started an anticoagulant treatment (2) other diseases than DVT, which anticoagulants are indicated for (3) Active bleeding (4) Hepatic impairment of Child-Pugh classification B and C (5) severe renal impairment(CLCR<30ml/min) (6) Pregnant, unwilling to practice contraception during the study, or lactating female

Related Information

Contact

Public contact
Name Yoshito Ogihara
Address 2-174 Edobashi Tsu city, Mie Mie Japan 514-8507
Telephone +81-59-231-5015
E-mail yoshito@clin.medic.mie-u.ac.jp
Affiliation Mie University Hospital
Scientific contact
Name Yoshito Ogihara
Address 2-174 Edobashi Tsu city, Mie Mie Japan 514-8507
Telephone +81-59-231-5015
E-mail yoshito@clin.medic.mie-u.ac.jp
Affiliation Mie University Hospital