Status:
RECRUITING
Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Venous Thromboembolic Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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: ...
Detailed Description
Up to one third of VTE patients receive concomitant AP therapy, with conflicting results on patient outcomes. Concomitant therapy (AC+AP) has been associated with a higher risk of bleeding (up to 3-fo...
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
- 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
Key Trial Info
Start Date :
August 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT05627375
Start Date
August 16 2023
End Date
December 1 2028
Last Update
March 18 2025
Active Locations (28)
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1
CHU Amiens
Amiens, France
2
CHU Angers
Angers, France
3
CHU Besançon - Hôpital Jean Minjoz
Besançon, France
4
CHRU Brest - Hôpital la Cavale Blanche
Brest, France