Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets
NCT ID: NCT05627375
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1400 participants
INTERVENTIONAL
2023-08-16
2028-12-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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strategy of full-dose anticoagulant therapy alone (AC)
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.
Full-dose anticoagulant therapy (AC)
Anticoagulant (AC) therapy: at the investigator's discretion in accordance with international recommendations for the management of DVT/PE
strategy of combined full-dose anticoagulant and antiplatelet therapies (AC+AP)
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
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Laurent BERTOLETTI, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
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CHU Amiens
Amiens, , France
CHU Angers
Angers, , France
CHU Besançon - Hôpital Jean Minjoz
Besançon, , France
CHRU Brest - Hôpital la Cavale Blanche
Brest, , France
Clinique du Parc - Castelnau-le -lez
Castelnau-le-Lez, , France
CHU Clermont-Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand, , France
CHU Dijon
Dijon, , France
CH le Corbusier - Firminy
Firminy, , France
CHU Grenoble - Hôpital la Tronche
Grenoble, , France
CH Le Puy - Hôpital Emile Roux
Le Puy-en-Velay, , France
CHU Limoges
Limoges, , France
HCL - Hôpital Edouard Herriot
Lyon, , France
HCL - Lyon Sud
Lyon, , France
APHM - Hôpital la Timone
Marseille, , France
CH du Forez - Montbrison
Montbrison, , France
CHU Montpellier
Montpellier, , France
CHU Nancy - Hôpitaux de Brabois
Nancy, , France
CHU Nantes - Hôpital Hôtel-Dieu
Nantes, , France
CHU de Nice - Hôpital Pasteur
Nice, , France
APHP - Hôpital Bicêtre
Paris, , France
APHP - Hôpital Européen Georges Pompidou HEGP
Paris, , France
APHP - Hôpital Louis Mourier
Paris, , France
CHU Rouen
Rouen, , France
CHU Saint-Etienne
Saint-Etienne, , France
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, , France
CH Toulon - Hôpital Sainte Musse
Toulon, , France
CHU Toulouse - Hôpital de Rangueil
Toulouse, , France
CHU Tours
Tours, , France
Countries
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Central Contacts
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Other Identifiers
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20PH285
Identifier Type: -
Identifier Source: org_study_id
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