Venous Thromboembolism in Renally Impaired Patients and Direct Oral Anticoagulants (VERDICT)
Renal Insufficiency
About this trial
This is an interventional treatment trial for Renal Insufficiency focused on measuring Renal insufficiency, Direct oral anticoagulants (DOA), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Venous Thromboembolism (VTE), Heparins
Eligibility Criteria
Inclusion Criteria:
- Patients with a moderate renal insufficiency defined by a creatinine clearance between 30 to 50 ml/min (Cockcroft and Gault formulae) or a severe renal insufficiency (between 15 to 29 ml/min)
- Patients with acute objectively confirmed symptomatic proximal deep-vein thrombosis (DVT) or pulmonary embolism (PE) (with or without deep-vein thrombosis), planned to be treated for at least 3 months
- Patients >18 years
- Life expectancy more than 3 months
- Social security affiliation
- Signed informed consent
Exclusion Criteria:
- Indication for anticoagulants other than VTE
- Active bleeding or a high risk of bleeding contraindicating anticoagulant treatment; a systolic blood pressure of more than 180 mm Hg or a diastolic blood pressure of more than 110 mm Hg
- Anticoagulation for more than 72 hours prior to randomization
- Chronic liver disease or chronic hepatitis
- Patient at high risk of bleeding
- Creatinine clearance <15 ml/min or end stage renal disease or indication for extra-renal dialysis
- Need for concomitant anti-platelet therapy other than aspirin 75-325 mg per day. However concomitant treatment with aspirin is discouraged in this population at bleeding risk.
- 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 pregnancy or expected pregnancy or no effective contraception
- Any contraindication listed in the local labeling of UFH, LMWH or VKA or oral anticoagulant.
- Cancer-associated VTE requiring long-term treatment with LMWH
- Life expectancy of less than 3 months.
Sites / Locations
- CH ARRAS
- Chu Tours
- CH d'Agen-Nérac
- Chu Amiens
- Chu Angers
- CH Besançon
- CHU de Bordeaux
- CHU La Cavale Blanche Brest
- HIA de Brest
- CHU Castelnau-le-Lez
- CH Louis Pasteur - Chartres
- Chu Clermont-Ferrand
- CHU Dijon
- Hôpital La Tronche Grenoble
- Hôpital Charles Foix - APHP Ivry sur Seine
- Chu Limoges
- CHU Lyon
- HCL - Hôpital Edouard Herriot
- Chu Montpellier
- CHU de Nantes - Hôpital Bellier
- CHU de Nantes - Hôpital Hôtel Dieu
- CHU Nice
- HEGP - APHP Paris
- Hôpital Louis Mourier- APHP Paris
- CHU de Rouen
- Chu Saint Etienne
- Chu Strasbourg
- CH Toulon
- HIA de Toulon
- CHU Toulouse
- CH de Valenciennes
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
DOA : Direct Oral Anticoagulants
SOC : Standard Of Care
The experimental group receiving DOA regimens: patients will be secondarily randomly assigned within DOAs group between: Apixaban (Eliquis® tablet) 10 mg bid for 7 days then 2.5 mg bid for 3 months Rivaroxaban (Xarelto® tablet) 15 mg bid for 21 days then 15 mg od for 3 months.
The control group receiving the standard of care (SOC), i.e. heparins/VKA regimen. Patients will receive the current recommended therapy: subcutaneous or intravenous UFH/VKA in case of severe renal insufficiency and subcutaneous LMWH/VKA in case of moderate renal insufficiency for at least 5 days. VKA will begin concomitantly and continue for 3 months.