Overview

Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets: the BAT-VTE

Status:
Not yet recruiting

Trial end date:
2028-12-01

Target enrollment:

Participant gender:

Summary

Venous ThromboEmbolism (VTE) and atherosclerotic cardiovascular disease share common risk factors and frequently coexist in the same patients. Their management requires use of antithrombotic agents: Anticoagulant (AC) for secondary prevention of Venous ThromboEmbolism (VTE) recurrence, antiplatelet (AP) for secondary prevention of Major Adverse ischemic Cardiovascular and Cerebrovascular Event (MACCE) in patients with atherosclerotic cardiovascular disease (coronary artery disease, atherosclerotic cerebrovascular disease, lower extremity peripheral arterial disease). Side effects of antithrombotic drugs are the 1st cause of emergency admission and hospitalization for an adverse drug reaction (mainly bleeding), and the combination of Anticoagulant (AC) with antiplatelet (AP) strongly increases this risk. Up to one third of Venous ThromboEmbolism (VTE) patients receive concomitant antiplatelet (AP) therapy, with conflicting results on patient outcomes. Concomitant therapy (Anticoagulant + antiplatelet) has been associated with a higher risk of bleeding (up to 3-fold) when aspirin was associated with vitamin-K antagonist (VKA) in a multicenter cohort study, or with direct oral anticoagulants (DOACs) for acute Venous ThromboEmbolism (VTE) in a post-hoc subgroup analysis. Conversely, patients with acute Venous ThromboEmbolism (VTE) in whom clinicians decided to maintain Anticoagulant (AC) + antiplatelet (AP) were found to have an increased risk of Major Adverse ischemic Cardiovascular and Cerebrovascular Event (MACCE) without any higher risk of bleeding, in a multicenter registry. However, in most cases, the type (aspirin or another) and indication (primary versus secondary prevention) of antiplatelet (AP) was unknown, as was the duration of the combination anticoagulant (AC) + antiplatelet (AP), and therefore these observational results may be confounded. Therefore, there is persistent equipoise regarding the benefit/risk of combining an antiplatelet therapy with anticoagulation in patients undergoing treatment for Venous ThromboEmbolism (VTE), when there is a prior history of atherosclerotic cardiovascular disease. This may explain why clinical practice varies widely.

Phase:

Phase 3

Details

Lead Sponsor:

Centre Hospitalier Universitaire de Saint Etienne

Collaborator:

Ministry of Health, France

Treatments:

Anticoagulants