Comparing antithrombotic therapies for patients with acute venous thromboembolism and a history of cardiovascular disease

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

This study is testing if combining blood thinners with another type of medication can help people with blood clots and a history of heart disease stay safe and healthy.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 1400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (other)
• Locations: 28 sites (Amiens and 27 other locations)
• Trial ID: NCT05627375 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of combining full-dose anticoagulant therapy with antiplatelet therapy in patients diagnosed with acute venous thromboembolism (VTE) who also have a history of stable atherosclerotic cardiovascular disease. The study will randomly assign participants to receive either anticoagulant therapy alone or in combination with antiplatelet therapy, monitoring outcomes related to bleeding risks and major adverse cardiovascular events. By addressing the conflicting evidence surrounding these treatment strategies, the trial seeks to provide clearer guidance for clinicians managing these patients.

Who should consider this trial

Good fit: Ideal candidates include patients with acute proximal deep vein thrombosis or pulmonary embolism who are also prescribed antiplatelet therapy for secondary prevention of cardiovascular disease.

Not a fit: Patients with active bleeding, high bleeding risk, or those who cannot provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to optimized treatment strategies that reduce the risk of adverse events in patients with both VTE and cardiovascular disease.

How similar studies have performed: While there have been conflicting results in previous studies regarding the combination of anticoagulant and antiplatelet therapies, this trial aims to provide definitive evidence in a randomized setting.

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

Where this trial is running

Amiens and 27 other locations

• CHU Amiens — Amiens, France (RECRUITING)
• CHU Angers — Angers, France (RECRUITING)
• CHU Besançon - Hôpital Jean Minjoz — Besançon, France (RECRUITING)
• CHRU Brest - Hôpital la Cavale Blanche — Brest, France (RECRUITING)
• Clinique du Parc - Castelnau-le -lez — Castelnau-le-Lez, France (RECRUITING)
• CHU Clermont-Ferrand - Hôpital Gabriel Montpied — Clermont-Ferrand, France (RECRUITING)
• CHU Dijon — Dijon, France (RECRUITING)
• CH le Corbusier - Firminy — Firminy, France (RECRUITING)
• CHU Grenoble - Hôpital la Tronche — Grenoble, France (RECRUITING)
• CH Le Puy - Hôpital Emile Roux — Le Puy-en-Velay, France (RECRUITING)
• CHU Limoges — Limoges, France (RECRUITING)
• HCL - Hôpital Edouard Herriot — Lyon, France (RECRUITING)
• HCL - Lyon Sud — Lyon, France (RECRUITING)
• APHM - Hôpital la Timone — Marseille, France (RECRUITING)
• CH du Forez - Montbrison — Montbrison, France (RECRUITING)
• CHU Montpellier — Montpellier, France (RECRUITING)
• CHU Nancy - Hôpitaux de Brabois — Nancy, France (RECRUITING)
• CHU Nantes - Hôpital Hôtel-Dieu — Nantes, France (RECRUITING)
• CHU de Nice - Hôpital Pasteur — Nice, France (RECRUITING)
• APHP - Hôpital Bicêtre — Paris, France (RECRUITING)
• APHP - Hôpital Européen Georges Pompidou HEGP — Paris, France (RECRUITING)
• APHP - Hôpital Louis Mourier — Paris, France (RECRUITING)
• CHU Rouen — Rouen, France (RECRUITING)
• CHU Saint-Etienne — Saint-Etienne, France (RECRUITING)
• CHU Strasbourg - Nouvel Hôpital Civil — Strasbourg, France (RECRUITING)
• CH Toulon - Hôpital Sainte Musse — Toulon, France (RECRUITING)
• CHU Toulouse - Hôpital de Rangueil — Toulouse, France (RECRUITING)
• CHU Tours — Tours, France (RECRUITING)

Study contacts

• Principal investigator: Laurent BERTOLETTI, MD PhD — Centre Hospitalier Universitaire de Saint Etienne
• Study coordinator: Laurent BERTOLETTI, MD PhD

Conditions: Venous Thromboembolic Disease, deep venous thrombosis, pulmonary embolism, anticoagulant, antiplatelet, Venous Thromboembolism, Direct oral anticoagulants, major adverse ischemic cardiovascular and cerebrovascular event