A Phase 3 interventional study of Full-dose anticoagulant therapy (AC) and Antiplatelet therapy (AP) in Venous Thromboembolic Disease, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 28 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Phase 3, Interventional, and Treatment
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.
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).
774 studies on the registry are indexed under Venous Thrombosis; 124 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 131 across 452 interventional studies indexed under Venous Thrombosis.
Browse Venous Thrombosis studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The 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.
Drug: Full-dose anticoagulant therapy (AC)
The 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
Drug: Full-dose anticoagulant therapy (AC) · Drug: Antiplatelet therapy (AP)
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)
Clinically relevant bleeding
Clinically relevant bleeding is composite of major bleeding events and clinically relevant non-major bleeding events).
Time frame: end of the full-dose treatment period, up to 12 months
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
Time frame: end of the full-dose AC treatment period, up to 12 months
Clinically relevant non-major bleeding
Time frame: end of the full-dose treatment period, up to 12 months
Major bleeding events
Time frame: end of the full-dose treatment period, up to 12 months
recurrent venous thromboembolism
proximal deep venous thromboembolism and/or pulmonary embolism symptomatic or incidental, and including fatal-PE
Time frame: end of the full-dose treatment period, up to 12 months
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),
Time frame: end of the full-dose treatment period, up to 12 months
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
Time frame: end of the full-dose treatment period, up to 12 months
Plan to share: No
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