drugset / Trial / NCT03692065
API-CAT STUDY for APIxaban Cancer Associated Thrombosis
Phase 3
Completed
1766 enrolled
Assistance Publique - Hôpitaux de Paris
Bristol-Myers Squibb · collab
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2018-10-11
- Primary completion
- 2024-09-06
- Completion
- 2024-10-20
Publications
- Mahe I, Chapelle C, Girard P, Carrier M, Palomares LJ, Samama CM, Helfer H, Gerotziafas G, Laporte S, Vicaut E, Mismetti P; API-CAT Study Group; API-CAT Investigators. Predictors of clinically relevant bleeding during extended anticoagulation for cancer-associated venous thromboembolism (API-CAT): a post-hoc analysis of a randomised, non-inferiority trial. Lancet Haematol. 2026 Jan;13(1):e41-e48. doi: 10.1016/S2352-3026(25)00291-1. Epub 2025 Dec 6.
- Mahe I, Carrier M, Mayeur D, Chidiac J, Vicaut E, Falvo N, Sanchez O, Grange C, Monreal M, Lopez-Nunez JJ, Otero-Candelera R, Le Gal G, Yeo E, Righini M, Robert-Ebadi H, Huisman MV, Klok FA, Westerweel P, Agnelli G, Becattini C, Bamias A, Syrigos K, Szmit S, Torbicki A, Verhamme P, Maraveyas A, Cohen AT, Ay C, Chapelle C, Meyer G, Couturaud F, Mismetti P, Girard P, Bertoletti L, Laporte S; API-CAT Investigators. Extended Reduced-Dose Apixaban for Cancer-Associated Venous Thromboembolism. N Engl J Med. 2025 Apr 10;392(14):1363-1373. doi: 10.1056/NEJMoa2416112. Epub 2025 Mar 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Apixaban | Small molecule | 2.5 mg | Oral |
| Comparator | Apixaban | Small molecule | 5 mg | Oral |