Best Antithrombotic Therapy in patients with acute Venous ThromboEmbolism while taking antiplatelets: the BAT-VTE

Phase 1

Recruiting

• Conditions: acute venous thromboembolism event; MedDRA version: 21.1Level: LLTClassification code: 10049918Term: Deep venous thrombosis proximal Class: 10047065; MedDRA version: 20.0Level: LLTClassification code: 10014521Term: Embolism pulmonary Class: 10038738; MedDRA version: 21.1Level: LLTClassification code: 10067625Term: Secondary prevention Class: 10042613; MedDRA version: 21.1Level: LLTClassification code: 10051615Term: Atherosclerotic cardiovascular disease Class: 10047065; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2022-500974-33-00
• Lead Sponsor: CHU De Saint Etienne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-06
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

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

Exclusion Criteria

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 antiphospholipide syndrome, with arterial thrombosis, Major cardiovascular and cerebrovascular event in the past 12 months for acute coronary syndrom, and in the past 6 months for cerebrovascular diseases and peripheral arterial diseases, Isolated sub-segmental pulmonary embolism

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified