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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Apixaban 2.5 MG Oral Tablet [ELIQUIS]

    Drug

    Apixaban 5 MG BID versus Apixaban 2.5 MG BID

Treatment groups

1,300 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: StandardActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of i) symptomatic VTE; ii) major bleeding and clinically relevant non major bleeding (CRNMB); iii) VTE and bleeding related death.

The primary outcome is a composite of rate of i) symptomatic VTE (includes iDDVT involving a new distal deep vein, proximal DVT or PE; ii) major bleeding and clinically relevant non major bleeding (CRNMB); iii) VTE and bleeding related death.

Time frame
1 year

Secondary outcomes

1

Individual components of the composite endpoint at 3 months and 1 year - Generic and venous disease-specific QOL scores at 1 year - Patient's compliance with treatment at 3 months - Serious adverse events during follow-up - PTS as measured at 1 year

as above

Time frame
1 year
2

Generic and venous disease-specific QOL scores at 1 year

QOL score

Time frame
1 year
3

Patient's observance with treatment at 3 months

Observance of the patient

Time frame
3 months
4

Serious adverse events during follow-up

Adverse events

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Geneva

Lead sponsor

Sunnybrook Health Sciences Centre

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: