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

Recruiting now · Phase 3

Conditions studied: Venous Thromboembolic Disease

In brief

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.

Key facts

Study ID

NCT05627375

Run by

Centre Hospitalier Universitaire de Saint Etienne

People needed

1400

Starts

2023-08-16

Expected to finish

2028-12-01

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CHU Amiens — Amiens, France (enrolling)
• CHU Angers — Angers, France (enrolling)
• CHU Besançon - Hôpital Jean Minjoz — Besançon, France (enrolling)
• CHRU Brest - Hôpital la Cavale Blanche — Brest, France (enrolling)
• Clinique du Parc - Castelnau-le -lez — Castelnau-le-Lez, France (enrolling)
• CHU Clermont-Ferrand - Hôpital Gabriel Montpied — Clermont-Ferrand, France (enrolling)
• CHU Dijon — Dijon, France (enrolling)
• CH le Corbusier - Firminy — Firminy, France (enrolling)
• CHU Grenoble - Hôpital la Tronche — Grenoble, France (enrolling)
• CH Le Puy - Hôpital Emile Roux — Le Puy-en-Velay, France (enrolling)
• CHU Limoges — Limoges, France (enrolling)
• HCL - Hôpital Edouard Herriot — Lyon, France (enrolling)
• HCL - Lyon Sud — Lyon, France (enrolling)
• APHM - Hôpital la Timone — Marseille, France (enrolling)
• CH du Forez - Montbrison — Montbrison, France (enrolling)
• CHU Montpellier — Montpellier, France (enrolling)
• CHU Nancy - Hôpitaux de Brabois — Nancy, France (enrolling)
• CHU Nantes - Hôpital Hôtel-Dieu — Nantes, France (enrolling)
• CHU de Nice - Hôpital Pasteur — Nice, France (enrolling)
• APHP - Hôpital Bicêtre — Paris, France (enrolling)
• APHP - Hôpital Européen Georges Pompidou HEGP — Paris, France (enrolling)
• APHP - Hôpital Louis Mourier — Paris, France (enrolling)
• CHU Rouen — Rouen, France (enrolling)
• CHU Saint-Etienne — Saint-Etienne, France (enrolling)
• CHU Strasbourg - Nouvel Hôpital Civil — Strasbourg, France (enrolling)

Full record on ClinicalTrials.gov

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