CompletedPhase 3

API-CAT STUDY for APIxaban Cancer Associated Thrombosis

Austria, Belgium1,766 participantsStarted 2018-10-11

Plain-language summary

The main objective is to determine whether a low-dose regimen of apixaban (2.5 mg bid) is non inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent venous thromboembolism (VTE) in patients with active cancer who have completed at least 6 months of anticoagulant therapy for treating a documented index event of proximal deep venous thrombosis (DVT) (symptomatic or incidental) or pulmonary embolism (symptomatic or incidental).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Proximal DVT is defined as DVT that involves at least the popliteal vein or a more proximal vein, demonstrated by imaging with compression ultrasound (CUS), including grey-scale or color-coded Doppler, or ascending contrast venography or contrast enhanced computed tomography or magnetic resonance imaging
✓. PE has to be demonstrated by imaging as follows:
✓. Incidental VTE is defined as proximal DVT or PE detected by imaging incidentally when a patient undergoes imaging studies as standard of care for the management of his or her malignancy or other reasons but not for a VTE suspicion(e.g. cancer diagnosis or staging).

Exclusion criteria

✕. intracranial or intraocular bleeding within the 6 months
✕. major surgery within 2 weeks prior to randomization
✕. overt major bleeding at time of randomization

What they're measuring

The incidence of an an adjudicated composite endpoint

Timeframe: During the treatment period (12 months)

Trial details

NCT IDNCT03692065

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-06

View on ClinicalTrials.gov More Cancer-associated Thrombosis trials