Venous Thrombosis
Conditions
Brief summary
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.
Interventions
DRUGRivaroxaban
Rivaroxaban 20 mg or 10 mg for 3 months
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18-90 * Outpatients with a first, acute (within 2 weeks), symptomatic, objectively confirmed isolated distal DVT * Compliance to the scheduled follow up plan * Ability and willing to participate and sign the informed consent.
Exclusion criteria
* Any absolute contraindication to anticoagulant treatment * Pregnancy or breast-feeding * Systolic pressure \> 180 mmHg or diastolic pressure \> 100 mmHg * Platelet count \< 100 × 10⁹ /L * Serum creatinine \> 180 mmol/L or creatinine clearance ≤30 ml/min * Liver disease associated with coagulopathy and high risk of bleeding * Clinically suspected or confirmed pulmonary embolism * Ipsilateral or contralateral proximal DVT * Any indication for long-term anticoagulation * Enrolled in another clinical trial simultaneously * Life expectancy \< 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographically confirmed recurrent venous thromboembolism | 6 months | Recurrent venous thromboembolism includes proximal extension of isolated distal DVT, new contralateral proximal DVT and pulmonary embolism. |
| Major or clinically relevant non-major bleeding events | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual component of primary outcomes (e.g. proximal extension, major bleeding) | 6 months | 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. |
| Residual vein occlusion | 6 months | — |
| Post-thrombotic syndrome | 6 months | — |
| All-cause death | 6 months | — |
Countries
China
Contacts
Primary ContactWeiguo Fu, PhD
Outcome results
None listed