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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborator: Ministry of Health, France
• Treatments: Anticoagulants

Criteria

Inclusion criteria

• Signed informed consent

• Patients with acute objectively confirmed symptomatic proximal deep-vein thrombosis (DVT) or pulmonary embolism (PE) (with or without deep-vein thrombosis). Proximal deep-vein thrombosis is defined as thrombosis involving at least the popliteal vein or a more proximal vein of the lower limb.

• Indication of full-dose anticoagulant therapy for at least 3 months.

• Prescription of antiplatelet therapy for secondary prevention of atherosclerotic cardiovascular diseases, at the time of VTE diagnosis

• Life expectancy more than 3 months

• Social security affiliation

Exclusion Criteria:

• Unable to give informed consent

• 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 5 days prior to randomization

• Active pregnancy or expected pregnancy or no effective contraception

• Isolated distal deep vein thrombosis

• Antiplatelet therapy prescribed for primary prevention of cardiovascular disease

• Indication to maintain a dual-antiplatelet therapy.

• Triple positive antiphospholipid syndrome, with arterial thrombosis

• Major cardiovascular and cerebrovascular event in the past 12 months for acute coronary syndrome, and in the past 6 months for cerebrovascular diseases and peripheral arterial diseases