Last updated on January 2020

REduced Dose Versus Full-dose of Direct Oral Anticoagulant After uNprOvoked Venous thromboEmbolism.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Venous Thromboembolism
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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