Patients with indications for long-term anticoagulation after VTE (i.e.
Conditions
Interventions
Trade Name: ELIQUIS 5 mg
Product Name: APIXABAN
Pharmaceutical Form: Capsule
Trade Name: XARELTO 20 mg
Product Name: RIVAROXABAN
Pharmaceutical Form: Capsule
Trade Name: ELIQUIS 2.5 mg
Product Name:
Sponsors
CHRU de BREST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients >18 years - Patients with indications for long-term anticoagulation after VTE (i.e.; symptomatic PE or proximal DVT) initially treated during 6 to 24 months: • Patients with multiple episodes of VTE, or • Patients with a first episode of unprovoked VTE • Patients with VTE associated with persistent risk factor, or • Patients for whom clinicians feel that indefinite anticoagulation is warranted. - Social security affiliation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1100
Exclusion criteria
Exclusion criteria: - Known allergy to rivaroxaban and apixaban - Unable or refusal to give informed consent - Isolated DVT - HERDOO2 score = 1 - Indication for anticoagulation other than DVT or PE (e.g.; atrial fibrillation, mechanic valves…) - Treatment with investigational drug in the past 1 month - Interruption of anticoagulation for 14 days or more before the inclusion - Chronic liver disease or chronic hepatitis - Patient considered at high risk of bleeding (eg: previous gastro-intestinal tract bleeding in the past three months, uncontrolled hypertension, etc.) - Creatinine clearance 100 mg per day - Concomitant use of a strong inhibitor of cytochrome P-450 3A4 (CYP3A4) (e.g., a protease inhibitor for human immunodeficiency virus infection or azole-antimycotics agents ketoconazole, itraconazole, voriconazole, posaconazole) or a CYP3A4 inducer (e.g., rifampin, carbamazepine, or phenytoin), - Active cancer of less than 6 months - Active pregnancy or expected pregnancy - No effective contraception in women of childbearing age - Life expectancy <12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that extended duration of anticoagulation using a reduced dose of DOAC is non-inferior to a full dose of DOAC for the risk of recurrent VTE in patients with unprovoked VTE who have been initially treated for 6 to 24 months;Secondary Objective: Key secondary objectives: if the main objective is verified, key secondary objectives are to demonstrate the superiority of a reduced dose of DOAC over a full dose of DOAC: - on the risk of major or clinically relevant non major bleeding and, if confirmed, - on the composite of recurrent VTE or major bleeding or clinically relevant non major bleeding. Other secondary outcomes are: - adjudicated major bleeding during the study treatment period - adjudicated mortality of other cause than recurrent VTE or major or clinically relevant non major bleeding during the study treatment period - arterial cardio-vascular events (myocardial infarction, stroke, cardio-vascular complication other than VTE) - treatment compliance - heterogeneity of the treatment effect on predefined strata. ;Primary end point(s): Adjudicated symptomatic objectively confirmed recurrent VTE (non fatal or fatal VTE) during the study treatment period.;Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 24 months;Secondary end point(s): The key secondary end points are: - adjudicated major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis) or clinically relevant non major bleeding during the study treatment period - and the composite of adjudicated recurrent VTE or major bleeding or non major clinically relevant bleeding during the study treatment period. Other secondary outcomes are: - adjudicated major bleeding during the study treatment period - adjudicated mortality of other cause than recurrent VTE or major or clinically relevant non major bleeding during the study treatment period. - arterial cardio-vascular events (myocardial infarction, stroke, cardio-vascular complication other than VTE) - Treatment compliance - heterogeneity of the treatment effect on predefined strata. | — |
Countries
France
Contacts
Public ContactFlorence Morvan
CHRU de Brest
Outcome results
None listed