Clinical trial · Interventional
Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban
Efficacy and Safety of Oral Rivaroxaban for the Treatment of Venous Thromboembolism in Patients With Active Cancer. A Pilot Study.
NCT02746185CI-TRIAL-00034319CASTA-DIVAcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study will compare the efficacy and safety of oral rivaroxaban and subcutaneous dalteparin in patients with cancer associated thrombosis. It is designed as a non-inferiority open label randomized multicenter trial with blinded adjudication of outcome events.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-molecular-weight heparin | Drug | — | UNRESOLVED |
| rivaroxaban | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Low-molecular-weight heparin
- description
- dalteparin, 200 IU/kg subcutaneously once daily for one month followed by 150 IU/kg subcutaneously once daily for 2 months
- interventionNames
- Drug: Low-molecular-weight heparin
- type
- EXPERIMENTAL
- label
- Rivaroxaban
- description
- rivaroxaban, orally, 15 mg twice daily for 3 weeks followed by 20 mg once daily for 9 weeks
- interventionNames
- Drug: rivaroxaban
Primary outcomes (4)
- measure
- Symptomatic DVT
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Social security affiliation * Written informed consent * Solid active cancer, high grade lymphoma or myeloma treated with Immunomodulatory drugs (IMiDs) (thalidomide or lenalidomide). Active cancer is defined as the presence of measurable disease or ongoing (or planned) chemotherapy, radiotherapy or targeted therapy at inclusion. * Histologically or cytologically proven cancer. * Symptomatic venous thromboembolism objectively confirmed diagnosed because of symptoms or discovered incidentally * High-risk of recurrent Venous thromboembolism (VTE) defined by a score of 0 or ≥ 1, using the following criteria: female sex (+1), lung cancer (+1), breast cancer (-1) non metastatic tumor (-2), previous VTE (+1). Exclusion Criteria: * Exclusive adjuvant hormonal treatment with no measurable residual disease * Sub-segmental isolated pulmonary embolism (PE) without associated proximal DVT * Isolated distal deep vein thrombosis (DVT) of the legs * Isolated upper-extremity DVT or superior vena cava thrombosis * Isolated visceral thrombosis * Platelet count \< 50 000 G/L * Active bleeding * Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C * Hemostatic defect with contraindication to anticoagulant treatment at therapeutic dosage * Vena cava filter at inclusion * Fibrinolytic therapy within 3 days preceding inclusion * Creatinine clearance \< 30 ml/min according to Cockcroft-Gault formula * Previous heparin-induced thrombocytopenia * Anticoagulant treatment at curative dosage for more than 3 days before inclusion * Pregnancy or lack of effective contraceptive treatment for women of childbearing age * Treatment with both strong CYP3A4 and P-glycoprotein (PgP) inhibitors: protease inhibitors for HIV disease, systemic ketoconazole * Treatment with a strong CYP3A4 inducer: rifampicin, carbamazepine, phenytoin. * Life expectancy \< 3 months * Eastern Cooperative Oncology Group (ECOG) level 3 or 4
References
Publications (2)
- DERIVEDPlanquette B, Bertoletti L, Charles-Nelson A, Laporte S, Grange C, Mahe I, Pernod G, Elias A, Couturaud F, Falvo N, Sevestre MA, Ray V, Burnod A, Brebion N, Roy PM, Timar-David M, Aquilanti S, Constans J, Bura-Riviere A, Brisot D, Chatellier G, Sanchez O, Meyer G, Girard P, Mismetti P; CASTA DIVA Trial Investigators. Rivaroxaban vs Dalteparin in Cancer-Associated Thromboembolism: A Randomized Trial. Chest. 2022 Mar;161(3):781-790. doi: 10.1016/j.chest.2021.09.037. Epub 2021 Oct 8. PMID 34627853
- DERIVEDRiaz IB, Fuentes HE, Naqvi SAA, He H, Sipra QR, Tafur AJ, Padranos L, Wysokinski WE, Marshall AL, Vandvik PO, Montori V, Bryce AH, Liu H, Badgett RG, Murad MH, McBane RD 2nd. Direct Oral Anticoagulants Compared With Dalteparin for Treatment of Cancer-Associated Thrombosis: A Living, Interactive Systematic Review and Network Meta-analysis. Mayo Clin Proc. 2022 Feb;97(2):308-324. doi: 10.1016/j.mayocp.2020.10.041. Epub 2021 Jun 22. PMID 34172290