Venous Thromboembolism in Renally Impaired Patients and Direct Oral Anticoagulants
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
In renally impaired patients with acute venous thromboembolism (VTE), standard-of-care (SOC)
anticoagulation, i.e. heparins-vitamin K antagonists (VKA), at therapeutic dosage is
associated with an increased risk of thromboembolic and bleeding complications compared to
patients with normal renal function. Direct oral anticoagulants (DOAs) have been shown to be
at least as effective and safe as SOC in VTE treatment. But in the clinical trials, moderate
renally impaired patients were poorly represented and patients with severe renal
insufficiency not at all. So no dose reduction was considered.
Surprisingly, DOAs have been approved for VTE treatment in moderate and severe renally
impaired patients. There is need to evaluate a reduced dose of DOAs for VTE treatment in
patients with moderate and severe renal insufficiency.
We plan to evaluate reduced doses of 2 DOAs (apixaban, rivaroxaban) compared to SOC in VTE
patients with moderate or severe renal insufficiency in terms of net clinical benefit
(recurrent VTE and major bleeding) at 3 months.
Phase:
Phase 3
Details
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborator:
Ministry of Health, France
Treatments:
Anticoagulants Apixaban Calcium heparin Heparin Rivaroxaban Vitamin K