The API-CALF Study: Apixaban to Treat Calf Vein Thrombosis (API-CALF)
Deep Vein Thrombosis
About this trial
This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring Isolated distal deep vein thrombosis, Anticoagulation, Direct oral anticoagulants
Eligibility Criteria
Inclusion Criteria:
Consecutive patients with acute (symptoms <10 days) symptomatic iDDVT diagnosed on leg CUS who have none of the following exclusion criteria and who provided informed consent to participate. Diagnosis of iDDVT is made in the presence of an incompressible distal deep vein (deep calf vein (posterior tibial, anterior tibial or peroneal veins) or muscular vein (soleal or gastrocnemius veins)).
Exclusion Criteria:
- Age < 18 years
- Ipsi or contralateral Proximal DVT
- Distal DVT involving the tibio-peroneal trunk (i.e. calf trifurcation)
- DVT occurring while on anticoagulation (started ≥48hours before DVT diagnosis); However, inpatients that developed their iDDVT while on prophylactic anticoagulation are eligible if their expected date of discharge is <6 days post randomization.
- Clinically suspected PE (patient eligible if PE ruled out with objective tests)
- Active cancer, receiving cancer treatment or cured for < 6 months
- Indication for long-term therapeutic anticoagulation (e.g. atrial fibrillation, mechanical heart valve…)
- Thrombocytopenia (platelet count <100 g/l)
- Severe renal impairment (creatinine clearance <30 ml/min)
- Liver disease (including Child-Pugh Class B and C) associated with coagulopathy
- Pregnant or breast-feeding woman
- Body weight >120kg or <40 kg
- Ongoing active bleeding or condition at high risk of bleeding with anticoagulation (e.g. peptic ulcer…)
- Treatment with daily NSAIDs (aspirin ≤160 mg/day or clopidogrel ≤75 mg day permitted)
- Allergy to Apixaban
- Use of concomitant drugs that significantly interact with Apixaban: strong inhibitors of P-gp and CYP3A4 or strong inducers of CYP3A4
- Treatment with anticoagulants at therapeutic dose >2 days after DVT diagnosis
- Life expectancy < 1 year
- Enrolled in another clinical trial within previous 30 days
- Inability or refusal to provide informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Experimental
Standard
After a conventional course of 7 days of Apixaban 10mg BID, Apixaban 2.5mg BID during 3 months.
After a conventional course of 7 days of Apixaban 10 mg BID, Apixaban 5 mg BID during 3 months.