The efficacy and safety of anticoagulant treatment is not established for patients with acute symptomatic isolated distal deep vein thrombosis (IDDVT). The latest Antithrombotic Therapy for VTE Disease Guideline suggested using the same anticoagulation as for patients with acute proximal DVT in patients with acute IDDVT. However, a single-center retrospective cohort study found therapeutic anticoagulation was associated with an increase risk of bleeding. Thus, this study aimed to assess the short-term risk of recurrent venous thrombotic events and bleeding events in patients with a first acute symptomatic IDDVT of the leg treated with prophylactic or therapeutic anticoagulant therapy with rivaroxaban.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
480
Rivaroxaban 20 mg or 10 mg for 3 months
Huadong Hospital affiliated to Fudan University
Shanghai, China
RECRUITINGShanghai General Hospital
Shanghai, China
RECRUITINGShanghai Wusong Hospital
Shanghai, China
RECRUITINGZhongshan Hospital, Fudan University
Shanghai, China
RECRUITINGRadiographically confirmed recurrent venous thromboembolism
Recurrent venous thromboembolism includes proximal extension of isolated distal DVT, new contralateral proximal DVT and pulmonary embolism.
Time frame: 6 months
Major or clinically relevant non-major bleeding events
Major bleeding events are defined according to the International Society on Thrombosis and Haemostasis criteria. Clinically relevant non-major bleeding events refer to which do not meet the mentioned criteria of major bleeding but need at least an unscheduled in-person consultant.
Time frame: 3 months
Individual component of primary outcomes (e.g. proximal extension, major bleeding)
Individual component of primary outcomes, including proximal extension of isolated distal DVT, new contralateral proximal DVT, new pulmonary embolism, major bleeding events, clinically relevant non-major bleeding events.
Time frame: 6 months
Residual vein occlusion
Time frame: 6 months
Post-thrombotic syndrome
Time frame: 6 months
All-cause death
Time frame: 6 months
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