Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets
BAT-VTE
1 other identifier
interventional
1,400
1 country
28
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: 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2023
Longer than P75 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2022
CompletedFirst Posted
Study publicly available on registry
November 25, 2022
CompletedStudy Start
First participant enrolled
August 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
March 18, 2025
March 1, 2025
4.3 years
November 16, 2022
March 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinically relevant bleeding
Clinically relevant bleeding is composite of major bleeding events and clinically relevant non-major bleeding events).
end of the full-dose treatment period, up to 12 months
Secondary Outcomes (6)
Net clinical benefit
end of the full-dose AC treatment period, up to 12 months
Clinically relevant non-major bleeding
end of the full-dose treatment period, up to 12 months
Major bleeding events
end of the full-dose treatment period, up to 12 months
recurrent venous thromboembolism
end of the full-dose treatment period, up to 12 months
arterial events
end of the full-dose treatment period, up to 12 months
- +1 more secondary outcomes
Study Arms (2)
strategy of full-dose anticoagulant therapy alone (AC)
EXPERIMENTALThe 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.
strategy of combined full-dose anticoagulant and antiplatelet therapies (AC+AP)
ACTIVE COMPARATORThe 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
Interventions
Anticoagulant (AC) therapy: at the investigator's discretion in accordance with international recommendations for the management of DVT/PE
Aspirin (at a daily dose ≤100 mg) or Clopidogrel (at a daily dose ≤75mg)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
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
APHP - Hôpital Européen Georges Pompidou HEGP
Paris, France
APHP - Hôpital Louis Mourier
Paris, France
CHU Rouen
Rouen, France
CHU Saint-Etienne
Saint-Etienne, France
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, France
CH Toulon - Hôpital Sainte Musse
Toulon, France
CHU Toulouse - Hôpital de Rangueil
Toulouse, France
CHU Tours
Tours, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent BERTOLETTI, MD PhD
CHU SAINT-ETIENNE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2022
First Posted
November 25, 2022
Study Start
August 16, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
March 18, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share