Evaluation of Rivaroxaban for Isolated Calf Deep Vein Thrombosis

JRCT ID: jRCTs041190009

Registered date:10/04/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: isolated calf deep vein thrombosis
• Date of first enrollment: 08/05/2019
• Target sample size: 150
• Study type: Interventional

Intervention(s)

Arm (1) oral administration with rivaroxaban + physical treatment
Arm (2) physical treatment

Outcome(s)

• Primary Outcome: Composite end point of occurrence of symptomatic or asymptomatic proximal deep vein thrombosis and, symptomatic non-fatal or fatal pulmonary embolism
• Secondary Outcome: Efficacy 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 maximum: Not applicable
• Gender: Both

Include criteria

Male 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

• Primary Sponsor: Ogihara Yoshito
• Source(s) of Monetary Support: Bayer Yakuhin, Ltd.