CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,766 enrolled
Drug / intervention
Apixaban 5 MGdrug
Likely dose
Apixaban 5 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03692065
NCT03692065Phase 3Completed
CompareCT.gov

Long-term Treatment of Cancer Associated VTE: Reduced vs Full Dose of Apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis

Assistance Publique - Hôpitaux de Paris·interventional·Posted Oct 2, 2018·Updated Feb 6, 2025

In Brief

A Phase 3 clinical trial evaluating Apixaban 5 MG for Cancer-associated Thrombosis. Completed, enrolled 1,766 participants across 114 sites in 11 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer-associated Thrombosis
CountriesAustria, Belgium, Canada, France, Greece, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom
CollaboratorsBristol-Myers Squibb

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 2, 2018
Enrollment StartOct 11, 2018
Primary CompletionSep 6, 2024
Study CompletionOct 20, 2024
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 7.8 years ago

Interventions

Apixaban 5 MGdrug

Subjects will be randomized (1:1 ratio) to apixaban 5 mg bid (full dose) or apixaban 2.5 mg bid (reduced-dose) using a centralized IWRS (double blind study).