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Recruiting Phase 3 NCT05627375

Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets

Trial Parameters

Condition Venous Thromboembolic Disease
Sponsor Centre Hospitalier Universitaire de Saint Etienne
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 1,400
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-08-16
Completion 2027-12
Interventions
Full-dose anticoagulant therapy (AC)Antiplatelet therapy (AP)

Brief 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 therapy (AC) for secondary prevention of 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 AC with AP strongly increases this risk.

Eligibility 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 * Isolate

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