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Venous Thromboembolic DiseasePhase 3BAT-VTENCT05627375

Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets

A Phase 3 study testing Full-dose anticoagulant therapy (AC) and Antiplatelet therapy (AP) in people with Venous Thromboembolic Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 28 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thromboembolic Disease
What is being tested?
Full-dose anticoagulant therapy (AC) and Antiplatelet therapy (AP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,400 participants
Where
28 sitesFrance
Study dates
16 Aug 2023to Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

28 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Laurent BERTOLETTI, MD PhD contact

(0)477829121 ext. +33

laurent.bertoletti@chu-st-etienne.fr

Carine LABRUYERE contact

(0)477120469 ext. +33

carine.labruyere@chu-st-etienne.fr

28 sites in 1 country

France28 sites, 28 recruiting

  • CHU Amiens

    Amiens

    Marie-Antoinette SEVESTRE-PIETRI, MD PhD

    Recruiting

  • CHU Angers

    Angers

    Pierre-Marie ROY, MD PhD

    Recruiting

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon

    Nicolas MENNEVEAU, MD PhD

    Recruiting

  • CHRU Brest - Hôpital la Cavale Blanche

    Brest

    Francis COUTURAUD, MD PhD

    Recruiting

  • Clinique du Parc - Castelnau-le -lez

    Castelnau-le-Lez

    Dominique BRISOT, MD

    Recruiting

  • CHU Clermont-Ferrand - Hôpital Gabriel Montpied

    Clermont-Ferrand

    Jeannot SCHMIDT, MD PhD

    Recruiting

  • CHU Dijon

    Dijon

    Nicolas FALVO, MD

    Recruiting

  • CH le Corbusier - Firminy

    Firminy

    François BALLEREAU, MD

    Recruiting

  • CHU Grenoble - Hôpital la Tronche

    Grenoble

    Gilles PERNOD, MD PhD

    Recruiting

  • CH Le Puy - Hôpital Emile Roux

    Le Puy-en-Velay

    Mathieu VALADIER, MD

    Recruiting

  • CHU Limoges

    Limoges

    Philippe LACROIX, MD PhD

    Recruiting

  • HCL - Hôpital Edouard Herriot

    Lyon

    Hélène DESMURS, MD

    Recruiting

  • HCL - Lyon Sud

    Lyon

    Claire GRANGE, MD

    Recruiting

  • APHM - Hôpital la Timone

    Marseille

    Gabrielle SARLON, MD PhD

    Recruiting

  • CH du Forez - Montbrison

    Montbrison

    Mikaël MARTINEZ, MD

    Recruiting

  • CHU Montpellier

    Montpellier

    Isabelle QUERE, MD PhD

    Recruiting

  • CHU Nancy - Hôpitaux de Brabois

    Nancy

    Stéphane ZUILY, MD PhD

    Recruiting

  • CHU Nantes - Hôpital Hôtel-Dieu

    Nantes

    Jérôme CONNAULT, MD

    Recruiting

  • CHU de Nice - Hôpital Pasteur

    Nice

    Emile FERRARI, MD PhD

    Recruiting

  • APHP - Hôpital Bicêtre

    Paris

    David MONTANI, MD PhD

    Recruiting

  • APHP - Hôpital Européen Georges Pompidou HEGP

    Paris

    Olivier SANCHEZ, MD PhD

    Recruiting

  • APHP - Hôpital Louis Mourier

    Paris

    Isabelle MAHE, MD PhD

    Recruiting

  • CHU Rouen

    Rouen

    Ygal BENHAMOU, MD

    Recruiting

  • CHU Saint-Etienne

    Saint-Etienne

    Laurent Bertoletti, MD PhD

    Recruiting

  • CHU Strasbourg - Nouvel Hôpital Civil

    Strasbourg

    Dominique STEPHAN, MD PhD

    Recruiting

  • CH Toulon - Hôpital Sainte Musse

    Toulon

    Antoine ELIAS, MD

    Recruiting

  • CHU Toulouse - Hôpital de Rangueil

    Toulouse

    Alessandra BURA-RIVIERE, MD PhD

    Recruiting

  • CHU Tours

    Tours

    Denis ANGOULVANT, MD PhD

    Recruiting

Other trials in France

About this study

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.

Read the 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-fold) when aspirin was associated with vitamin-K antagonist (VKA) in a multicenter cohort study, or with direct oral anticoagulants (DOACs) for acute VTE in a post-hoc subgroup analysis. Conversely, patients with acute VTE in whom clinicians decided to maintain AC+AP were found to have an increased risk of MACCE without any higher risk of bleeding, in a multicenter registry. However, in most cases, the type (aspirin or another) and indication (primary versus secondary prevention) of AP was unknown, as was the duration of the combination AC+AP, and therefore these observational results may be confounded. Therefore, there is persistent equipoise regarding the benefit/risk of combining an antiplatelet therapy with anticoagulation in patients undergoing treatment for VTE, when there is a prior history of atherosclerotic cardiovascular disease. This may explain why clinical practice varies widely.

Considering the conflicting data about the risk of bleeding in patients on AP therapy for secondary prevention, who need to start full-dose anticoagulant therapy for acute VTE, a randomized trial comparing the two strategies, in patients with acute VTE and with history of stable atherosclerotic cardiovascular disease is needed and justified.

The investigators hypothesize that a strategy based on the prescription of a full-dose AC therapy alone will decrease the risk of bleeding, when compared to the the strategy of combined AP and full-dose AC therapies, and that this strategy will translate in a positive net clinical benefit (a composite of clinically relevant bleeding, recurrent venous thromboembolism, and major adverse ischemic cardiovascular and cerebrovascular events).

Being tested
Full-dose anticoagulant therapy (AC), Antiplatelet therapy (AP)
Keywords
deep venous thrombosis, pulmonary embolism, anticoagulant, antiplatelet, Venous Thromboembolism, Direct oral anticoagulants, major adverse ischemic cardiovascular and cerebrovascular event, secondary prevention
Medical subject headings
Venous Thrombosis, Pulmonary Embolism, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Full-dose anticoagulant therapy (AC)Drug

    Anticoagulant (AC) therapy: at the investigator's discretion in accordance with international recommendations for the management of DVT/PE

  • Antiplatelet therapy (AP)Drug

    Aspirin (at a daily dose ≤100 mg) or Clopidogrel (at a daily dose ≤75mg)

Study groups in NCT05627375
Study groupRoleWhat they receive
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.
Receives: Drug: Full-dose anticoagulant therapy (AC)
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
Receives: Drug: Full-dose anticoagulant therapy (AC); Drug: Antiplatelet therapy (AP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinically relevant bleeding

    Clinically relevant bleeding is composite of major bleeding events and clinically relevant non-major bleeding events).

    Measured: end of the full-dose treatment period, up to 12 months

Secondary outcomes (6)

  1. Net clinical benefit

    Net clinical benefit is defined by the composite of clinically relevant bleeding, recurrent venous thromboembolism, and major adverse ischemic cardiovascular and cerebrovascular events

    Measured: end of the full-dose AC treatment period, up to 12 months

  2. Clinically relevant non-major bleeding

    Measured: end of the full-dose treatment period, up to 12 months

  3. Major bleeding events

    Measured: end of the full-dose treatment period, up to 12 months

  4. recurrent venous thromboembolism

    proximal deep venous thromboembolism and/or pulmonary embolism symptomatic or incidental, and including fatal-PE

    Measured: end of the full-dose treatment period, up to 12 months

  5. arterial events

    major adverse cardiovascular and cerebrovascular events (nonfatal ischemic stroke, nonfatal myocardial infarction, acute lower limb ischemia, lower limb amputation or revascularization for vascular causes, cardiovascular deaths),

    Measured: end of the full-dose treatment period, up to 12 months

  6. venous thromboembolism (VTE) sequels

    post-thrombotic syndrome (defined as a Villalta score up to 4) and post-PE syndrome (defined as the combination of a persistant dyspnea with a NYHA (New York Heart Association) scale more than I with residual vascular obstruction on lung scan

    Measured: end of the full-dose treatment period, up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2022
  2. Study start16 Aug 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05627375
Sponsor's protocol ID
20PH285
Acronym
BAT-VTE
Status last verified
May 2026
First submitted
16 Nov 2022
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Full-dose anticoagulant therapy (AC) and Antiplatelet therapy (AP) in people with Venous Thromboembolic Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 28 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laurent BERTOLETTI, MD PhD ((0)477829121 ext. +33, laurent.bertoletti@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically relevant bleeding (time frame: end of the full-dose treatment period, up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05627375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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