REduced Dose Versus Full-dose of Direct Oral Anticoagulant After uNprOvoked Venous thromboEmbolism. (RENOVE)
Venous Thromboembolism
About this trial
This is an interventional prevention trial for Venous Thromboembolism focused on measuring Venous Thromboembolism, Anticoagulant, Direct oral anticoagulant, risk of recurrent venous thromboembolism, anticoagulant-related bleeding
Eligibility 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 (-15 days) to 24 months (+ 3 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.
Exclusion Criteria:
- Known allergy to rivaroxaban and apixaban, allergy to any of the excipients
- Indication for therapeutic dose anticoagulant therapy
- Unable or refusal to give informed consent
- Isolated distal 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 except for patients benefiting from an anticoagulant at therapeutic doses for the initial pathology
- 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.)
- Renal insufficiency with creatinine <25 ml / min on Cockcroft and Gault formula
- Antiphospholipid syndrome
- Dual anti-platelet therapy or aspirin at dosage >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
Sites / Locations
- CHU Amiens-Picardie
- CHU Angers
- CH d'Arras
- CHU de Besançon - Hôpital Jean Minjoz
- CH Bordeaux
- HIA Brest
- CHRU de Brest
- Clinique de Clapiers
- HIA Percy
- Cabinet médical
- CHU de Clermont Ferrand - Hôpital Gabriel Montpied
- APHP Hôpital Louis Mourier
- CHU de Dijon
- CHU de Grenoble - Hôpital Nord Michallon
- GH Le Havre
- CH Le Mans
- CHU de Limoges - Hôpital de Dupuytren
- CH Morlaix
- Chru Nancy
- CHU de Nantes
- CHU de Nice - Hôpital Pasteur
- CHU Nîmes
- CHR Orléans
- Hôpital de Cochin
- HEGP
- CHU Paris Nord Val de Seine
- HEGP
- Kremlin Bicêtre
- CH de Périgueux
- CH de Quimper
- CHU de Rennes - Hôpital Sud
- CHU de ROUEN
- CH de Saint Brieuc - Hôpital Yves Le Foll
- CHU de Saint Etienne - Hôpital Nord
- CH de Toulon - Hôpital Sainte-Musse
- HIA Sainte-Anne
- CHU de Toulouse - Hôpital de Rangueil
- CHU de Tours - Hôpital Trousseau
- CH Valenciennes
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Reduced dose of DOAC
Full dose of DOAC
A reduced dose of DOAC (apixaban 2.5 mg twice daily or rivaroxaban 10 mg once daily) during a mean follow-up period of 36 months (12 to 65 months)
A full dose of DOAC (Apixaban 5 mg twice daily or Rivaroxaban 20 mg once daily) during a mean follow-up period of 36 months (12 to 65 months).