Research & Innovation

COVET

Clinical Trials

COVET

Comparison of Oral anticoagulants for extended VEnous Thromboembolism (COVET)

Physician & Study Coordinator

Study Coordinator

Susan Hahn
484-526-7825

susan.hahn2@sluhn.org

Close

Synopsis

Synopsis:  The COVET study is a multi-center, randomized, open-label study of approximately 3000 patients who have confirmed acute symptomatic and unprovoked DVT/PE, have completed initial treatment of oral anticoagulation therapy for 3-12 months and are at high risk for recurrent VTE. Eligible patients who consent to participate in the study will be randomized to warfarin, apixaban, or rivaroxaban.

This will be a multi-center trial conducted in the United States and Canada. Patients will be treated for a period of 12 months (see Figure). Treatment beyond this will be at the discretion of the treating physician.

Close

Inclusion Criteria
  • Have confirmed acute, symptomatic and unprovoked DVT/PE.
  • Have completed an initial treatment course of oral anticoagulant therapy for 3-12 months.
  • At high risk for recurrent venous thromboembolism after completion of the initial treatment course.
  • Have the capacity to understand and sign an informed consent form.
  • Be 18 years of age and older.
  • Under the direct care of a physician for treatment of VTE for the length of time in the study.

Close

Exclusion Criteria
  • creatinine clearance (CrCl) < 30 mL/min as determined by Cockcroft-Gault formula
  • significant liver disease (Child-Pugh B or C)
  • concomitant use of medications that are strong P-glycoprotein or CYP3A4 inducers/inhibitors
  • life expectancy < 3 months
  • Currently pregnant or breast feeding
  • Active Cancer defined as:
  • Diagnosed with cancer within the past 6 months; or
  • Recurrent, regionally advanced or metastatic disease;
  • Currently receiving treatment or have received any treatment for cancer during the 6 months prior to randomization; or
  • A hematologic malignancy not in complete remission
  • Unwilling/ unlikely to agree to follow up

Close