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Clinical Trials in France / NCT05627375
Recruiting Phase 3

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

NCT05627375 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Phase
Phase 3
Started
2023-08-16
Last updated
2026-05-08

Condition(s) studied

Venous Thromboembolic Disease

Investigational drug(s) / intervention(s)

Full-dose anticoagulant therapy (AC)Antiplatelet therapy (AP)

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

Antiplatelet therapy (AP): Aspirin (at a daily dose ≤100 mg) or Clopidogrel (at a daily dose ≤75mg)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Clinically relevant bleeding — end of the full-dose treatment period, up to 12 months
    Clinically relevant bleeding is composite of major bleeding events and clinically relevant non-major bleeding events).

Trial sites (28)

FacilityCityRegionStatus
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

More Centre Hospitalier Universitaire de Saint Etienne trials in France

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Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome Recruiting
Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection Active, not recruiting
Therapeutic Fasting and Immune Aging Starting soon
Individualized Dose of Fibrinogen Following Cardiopulmonary Bypass Starting soon

Other trials for the same condition

Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure Recruiting
Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study Recruiting
Cohort for Monitoring Patients With Venous Thromboembolic Disease Recruiting
THROmbinography in Pregnant Woman and in Vitro Action of Low Molecular Weight HEparin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05627375 on ClinicalTrials.gov ↗ ← All trials in France