Clinical trial · Observational
Management of Atrial Fibrillation in Patients With Cancer (MAFIC Study)
Safety and Efficacy of Switching From Direct Oral Anticoagulants to Low Molecular Weight Heparin in Cancer Patients With Atrial Fibrillation During Antineoplastic Therapy
NCT04508855CI-TRIAL-00079264MAFICwithdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not enough participants
Summary
Brief summary (as posted)
The primary objective is to assess the safety and efficacy of switching from direct oral anticoagulants to low molecular weight heparin in cancer patients during antineoplastic therapy
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 |
|---|---|---|---|
| Atrial Fibrillation | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low molecular weight heparin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cancer patients with atrial fibrillation
- description
- All patients will be assigned to receive subcutaneous LMWH in therapeutic doses More specifically the regimens will be as follows: Tinzaparin 175 units/Kg once daily; Enoxaparin 1unit/kg twice daily; Fondaparinux \<50 kg, 5 mg SC once daily, 50-100 kg, 7.5 mg SC once daily, \>100 kg, 10 mg SC once daily; Bemiparin 115 IU/kg once daily; \<50kg, 5000IU, 50-70kg, 7.500 IU, \>70kg, 10000IU Nadroparin: Patients weighing 40 to 100 kg: SC, 171 anti-factor Xa IU per kg of body weight once a day; patients weighing over 100 kg will not receive nadroparin because a treatment dosage has not been established; Dalteparin: 200 units IU/kg SC daily for 30 days, then 150 units IU/Kg SC daily Dose adjustments will occur only in case of renal insufficiency according to the medicine's SPC The treatment with the LMWH will last at least during the period of active antineoplastic therapy of cancer patients
- interventionNames
- Drug: Low molecular weight heparin
Primary outcomes (2)
- measure
- Major bleeding
- timeFrame
- 6 months
- description
- Death or a decrease in hemoglobin level of ≥ 2 g/dL over 24 hours or the need for transfusion of ≥ 2 units of packed red cells or clinically overt bleeding at critical site (eg, intracranial, retroperitoneal)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects diagnosed with cancer other than basal-cell or squamous-cell skin cancer which was objectively confirmed and are programmed for antineoplastic treatment 2. Subjects between 18 to 75 years of age at inclusion 3. Subjects must weigh at least 40 kg at inclusion 4. Subjects receiving direct oral anticoagulant treatment (rivaroxaban, dabigatran, apixaban, edoxaban) for prevention of stroke and systemic embolism in non-valvular atrial fibrillation Exclusion Criteria: 1. Patients that have active or serious bleeding within the previous two weeks 2. Patients that have conditions associated with high bleeding risk (active peptic ulcer, recent neurosurgery 3. Patients with platelet count below 50000 per cubic millimeter 4. Patients who have contraindications to heparin (heparin-induced thrombocytopenia) 5. Patients with calculated creatinine clearance \< 30 ml/min using the Cockcroft-Gault formula 6. Women who are pregnant 7. Life expectancy less than 6 months 8. Anticoagulation contraindications 9. Recent brain surgery within 6 months 10. Vascular surgery within 6 months
References
Publications (5)
- BACKGROUNDCamm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available. PMID 22922413
- BACKGROUNDHu YF, Liu CJ, Chang PM, Tsao HM, Lin YJ, Chang SL, Lo LW, Tuan TC, Li CH, Chao TF, Chung FP, Liao JN, Chen TJ, Chen SA. Incident thromboembolism and heart failure associated with new-onset atrial fibrillation in cancer patients. Int J Cardiol. 2013 May 10;165(2):355-7. doi: 10.1016/j.ijcard.2012.08.036. Epub 2012 Sep 16. No abstract available. PMID 22989607
- BACKGROUNDLee AY, Levine MN, Baker RI, Bowden C, Kakkar AK, Prins M, Rickles FR, Julian JA, Haley S, Kovacs MJ, Gent M; Randomized Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer (CLOT) Investigators. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med. 2003 Jul 10;349(2):146-53. doi: 10.1056/NEJMoa025313. PMID 12853587
- BACKGROUNDYoung AM, Marshall A, Thirlwall J, Chapman O, Lokare A, Hill C, Hale D, Dunn JA, Lyman GH, Hutchinson C, MacCallum P, Kakkar A, Hobbs FDR, Petrou S, Dale J, Poole CJ, Maraveyas A, Levine M. Comparison of an Oral Factor Xa Inhibitor With Low Molecular Weight Heparin in Patients With Cancer With Venous Thromboembolism: Results of a Randomized Trial (SELECT-D). J Clin Oncol. 2018 Jul 10;36(20):2017-2023. doi: 10.1200/JCO.2018.78.8034. Epub 2018 May 10. PMID 29746227
- BACKGROUNDRaskob GE, van Es N, Verhamme P, Carrier M, Di Nisio M, Garcia D, Grosso MA, Kakkar AK, Kovacs MJ, Mercuri MF, Meyer G, Segers A, Shi M, Wang TF, Yeo E, Zhang G, Zwicker JI, Weitz JI, Buller HR; Hokusai VTE Cancer Investigators. Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism. N Engl J Med. 2018 Feb 15;378(7):615-624. doi: 10.1056/NEJMoa1711948. Epub 2017 Dec 12.