Status:
WITHDRAWN
Management of Atrial Fibrillation in Patients With Cancer (MAFIC Study)
Lead Sponsor:
AHEPA University Hospital
Collaborating Sponsors:
Theagenio Cancer Hospital
Conditions:
Cancer
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Brief Summary
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
Detailed Description
This is a single-arm prospective observational study aiming to explore the safety and efficacy of switching from direct oral anticoagulants (DOAC) to low molecular weight heparin (LMWH) in cancer pati...
Eligibility Criteria
Inclusion
- Subjects diagnosed with cancer other than basal-cell or squamous-cell skin cancer which was objectively confirmed and are programmed for antineoplastic treatment
- Subjects between 18 to 75 years of age at inclusion
- Subjects must weigh at least 40 kg at inclusion
- Subjects receiving direct oral anticoagulant treatment (rivaroxaban, dabigatran, apixaban, edoxaban) for prevention of stroke and systemic embolism in non-valvular atrial fibrillation
Exclusion
- Patients that have active or serious bleeding within the previous two weeks
- Patients that have conditions associated with high bleeding risk (active peptic ulcer, recent neurosurgery
- Patients with platelet count below 50000 per cubic millimeter
- Patients who have contraindications to heparin (heparin-induced thrombocytopenia)
- Patients with calculated creatinine clearance \< 30 ml/min using the Cockcroft-Gault formula
- Women who are pregnant
- Life expectancy less than 6 months
- Anticoagulation contraindications
- Recent brain surgery within 6 months
- Vascular surgery within 6 months
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04508855
Start Date
August 1 2020
End Date
December 1 2023
Last Update
July 30 2024
Active Locations (2)
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1
AHEPA University Hospital
Thessaloniki, Greece, 54636
2
Theagenio Cancer Hospital
Thessaloniki, Greece