The API-CALF Study: Apixaban to Treat Calf Vein Thrombosis
ConditionDeep Vein Thrombosis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-120
SponsorUniversity Hospital, Geneva
About this trial
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
Eligibility criteria
Qualifiers
None
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Apixaban 2.5 MG Oral Tablet [ELIQUIS]
Treatment groups
1,300 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
University Hospital, Geneva
Lead sponsor
Sunnybrook Health Sciences Centre
Collaborator
Source ClinicalTrials.gov