Tinzaparin Lead-In to Prevent the Post-Thrombotic Syndrome

Who can take part

• Patients with objectively confirmed acute (i.e. onset of symptoms <10 days) symptomatic iliac or common femoral DVT (DVT diagnosis will be made with a Compression Ultrasound (CUS) according to standardized consensus criteria)

Who cannot take part

• Concomitant use of drugs that interact with rivaroxaban (i.e. keto- or itraconazole, ritonavir)
• Need for treatment with daily NSAIDs or antiplatelet agent (ibuprofen < 1200 mg/day, aspirin ≤ 160 mg/day or clopidogrel ≤ 75 mg/day are permitted)
• Treatment with therapeutic doses of anticoagulants for > 72 hours
• History of ipsilateral DVT (distal and/or proximal)
• Active cancer
• Allergy or hypersensitivity to heparin or rivaroxaban, including heparin induced thrombocytopenia
• Anticoagulant therapy contraindicated because of presence of active bleeding or condition with high risk of bleeding (e.g. peptic ulcer, acute or subacute septic endocarditis, uncontrolled severe hypertension, other)
• Liver disease (including Child-Pugh Class B and Class C) associated with coagulopathy
• Mechanical heart valve
• Antiphospholipid syndrome
• Impaired renal function (creatinine clearance < 30 ml/min according to Cockcroft-Gault formula)
• Thrombocytopenia (platelet count < 100 x 109/L)
• Age < 18 years
• Thrombolysis or other invasive early thrombus removal technique to treat DVT or PE
• Pregnant or breast feeding
• Body weight > 120 kg or < 40 kg
• Sulphite sensitivity
• Lactose sensitivity
• Life expectancy < 1 year
• Unable or unwilling to provide informed consent