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

ConditionVenous Thromboembolic Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

1,400 Participants
are divided into 2 treatment groups
Group A: strategy of full-dose anticoagulant therapy alone (AC)Experimental treatment 1 intervention
Group B: strategy of combined full-dose anticoagulant and antiplatelet therapies (AC+AP)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

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

Time frame
end of the full-dose AC treatment period, up to 12 months
2

Clinically relevant non-major bleeding

Time frame
end of the full-dose treatment period, up to 12 months
3

Major bleeding events

Time frame
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

Time frame
end of the full-dose treatment period, up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Saint Etienne

Lead sponsor

Ministry of Health, France

Collaborator

Source ClinicalTrials.gov
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