CTIS2022-500974-33-00
Recruiting
Phase 1
Best Antithrombotic Therapy in patients with acute Venous ThromboEmbolism while taking antiplatelets: the BAT-VTE - 20PH285
CHU De Saint Etienne0 sites1,400 target enrollmentDecember 6, 2022
Conditionsacute venous thromboembolism eventMedDRA version: 21.1Level: LLTClassification code: 10049918Term: Deep venous thrombosis proximal Class: 10047065MedDRA version: 20.0Level: LLTClassification code: 10014521Term: Embolism pulmonary Class: 10038738MedDRA version: 21.1Level: LLTClassification code: 10067625Term: Secondary prevention Class: 10042613MedDRA version: 21.1Level: LLTClassification code: 10051615Term: Atherosclerotic cardiovascular disease Class: 10047065Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- acute venous thromboembolism event
- Sponsor
- CHU De Saint Etienne
- Enrollment
- 1400
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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