The API-CALF Study: Apixaban to Treat Calf Vein Thrombosis
Status:
Not yet recruiting
Trial end date:
2027-08-31
Target enrollment:
Participant gender:
Summary
Isolated distal DVT (iDDVT) is the most frequent clinical presentation of VTE and is
associated with a significant morbidity and risks of long-term complications. Data from
clinical trials highlighted that patients with iDDVT might require some level of AC
treatment. However, the optimal anticoagulant intensity is uncertain, and it is plausible
that the best benefit/risk ratio for AC might be achieved with lower intensity doses rather
than therapeutic doses.
The principal research question of the Apixaban to treat calf vein thrombosis (API-CALF)
study is to determine whether, after a conventional course of 7 days of Apixaban 10mg BID,
Apixaban 2.5mg BID (experimental arm) is non inferior to Apixaban 5 mg BID (standard arm) in
preventing VTE recurrence and bleeding in patients with iDDVT. Patients will be treated with
Apixaban for a total of 3 months. In that perspective we will conduct an international
multicentre open-label assessor-blinded study