Last updated on June 2019

Venous Thromboembolism in Renally Impaired Patients and Direct Oral Anticoagulants

Are you eligible to participate in this study?

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

  • Conditions: Renal Failure
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.