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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Laurent BERTOLETTI, MD PhD — Centre Hospitalier Universitaire de Saint Etienne
• Study coordinator: Laurent BERTOLETTI, MD PhD
• Email: laurent.bertoletti@chu-st-etienne.fr
• Phone: (0)477829121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.