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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Inclusion criteria - Signed willing to sign a consent form - 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 Who Should NOT Join This Trial: - Unable to give willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Full-dose anticoagulant therapy (AC)

Anticoagulant (AC) therapy: at the investigator's discretion in accordance with international recommendations for the management of DVT/PE

DRUG

Antiplatelet therapy (AP)

Aspirin (at a daily dose ≤100 mg) or Clopidogrel (at a daily dose ≤75mg)

Locations (20)

CHU Amiens
Amiens, France
CHU Angers
Angers, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, France
CHRU Brest - Hôpital la Cavale Blanche
Brest, France
Clinique du Parc - Castelnau-le -lez
Castelnau-le-Lez, France
CHU Clermont-Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand, France
CHU Dijon
Dijon, France
CH le Corbusier - Firminy
Firminy, France
CHU Grenoble - Hôpital la Tronche
Grenoble, France
CH Le Puy - Hôpital Emile Roux
Le Puy-en-Velay, France
CHU Limoges
Limoges, France
HCL - Hôpital Edouard Herriot
Lyon, France
HCL - Lyon Sud
Lyon, France
APHM - Hôpital la Timone
Marseille, France
CH du Forez - Montbrison
Montbrison, France
CHU Montpellier
Montpellier, France
CHU Nancy - Hôpitaux de Brabois
Nancy, France
CHU Nantes - Hôpital Hôtel-Dieu
Nantes, France
CHU de Nice - Hôpital Pasteur
Nice, France
APHP - Hôpital Bicêtre
Paris, France