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New treatment option for Venous Thromboembolic Disease
Official title Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets
ClinicalTrials.gov ID: NCT05627375
What this study is testing
What is Full-dose anticoagulant therapy (AC)?
Full-dose anticoagulant therapy (AC) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for venous thromboembolic disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed informed consent
- Patients with acute objectively confirmed symptomatic proximal deep-vein thrombosis (DVT) or pulmonary embolism (PE) (with or without deep-vein...
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Besançon, France
- Brest, France
- Castelnau-le-Lez, France
- Clermont-Ferrand, France
- Dijon, France
- Firminy, France
- Grenoble, France
- Le Puy-en-Velay, France
- Limoges, France
- Lyon, France
- Marseille, France
- Montbrison, France
- Montpellier, France
- Nancy, France
- Nantes, France
- Nice, France
- Paris, France
- Rouen, France
+ 5 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Besançon, France; Brest, France; Castelnau-le-Lez, France; Clermont-Ferrand, France and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.