Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets
Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
CHU Amiens
RECRUITING
Amiens
CHU Angers
RECRUITING
Angers
CHU Besançon - Hôpital Jean Minjoz
RECRUITING
Besançon
CHRU Brest - Hôpital la Cavale Blanche
RECRUITING
Brest
Clinique du Parc - Castelnau-le -lez
RECRUITING
Castelnau-le-lez
CHU Clermont-Ferrand - Hôpital Gabriel Montpied
RECRUITING
Clermont-ferrand
CHU Dijon
RECRUITING
Dijon
CH le Corbusier - Firminy
RECRUITING
Firminy
CHU Grenoble - Hôpital la Tronche
RECRUITING
Grenoble
CH Le Puy - Hôpital Emile Roux
RECRUITING
Le Puy-en-velay
CHU Limoges
RECRUITING
Limoges
HCL - Hôpital Edouard Herriot
RECRUITING
Lyon
HCL - Lyon Sud
RECRUITING
Lyon
APHM - Hôpital la Timone
RECRUITING
Marseille
CH du Forez - Montbrison
RECRUITING
Montbrison
CHU Montpellier
RECRUITING
Montpellier
CHU Nancy - Hôpitaux de Brabois
RECRUITING
Nancy
CHU Nantes - Hôpital Hôtel-Dieu
RECRUITING
Nantes
CHU de Nice - Hôpital Pasteur
RECRUITING
Nice
APHP - Hôpital Bicêtre
RECRUITING
Paris
APHP - Hôpital Européen Georges Pompidou HEGP
RECRUITING
Paris
APHP - Hôpital Louis Mourier
RECRUITING
Paris
CHU Rouen
RECRUITING
Rouen
CHU Saint-Etienne
RECRUITING
Saint-etienne
CHU Strasbourg - Nouvel Hôpital Civil
RECRUITING
Strasbourg
CH Toulon - Hôpital Sainte Musse
RECRUITING
Toulon
CHU Toulouse - Hôpital de Rangueil
RECRUITING
Toulouse
CHU Tours
RECRUITING
Tours
Contact Information
Primary
Laurent BERTOLETTI, MD PhD
laurent.bertoletti@chu-st-etienne.fr
(0)477829121
Backup
Carine LABRUYERE
carine.labruyere@chu-st-etienne.fr
(0)477120469
Time Frame
Start Date:2023-08-16
Estimated Completion Date:2028-12
Participants
Target number of participants:1400
Treatments
Experimental: strategy of full-dose anticoagulant therapy alone (AC)
The experimental group receiving full-dose anticoagulant therapy alone (AC).~Anticoagulant (AC) therapy :at the investigator's discretion in accordance with international recommendations for the management of DVT/PE Antiplatelet therapy will be stopped.
Active_comparator: strategy of combined full-dose anticoagulant and antiplatelet therapies (AC+AP)
The control group receiving the standard of care: Antiplatelet therapy will be combined to full-dose anticoagulant therapy.~Anticoagulant (AC) therapy :at the investigator's discretion in accordance with international recommendations for the management of DVT/PE~Antiplatelet (AP) therapy : Aspirin or Clopidogrel