Actively Recruiting
Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2026-05-08
1400
Participants Needed
28
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Saint Etienne
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates the best antithrombotic treatment for patients with acute venous thromboembolism (VTE) who are also taking antiplatelet therapy due to a history of stable atherosclerotic cardiovascular disease. VTE and atherosclerotic cardiovascular disease share common risk factors and often occur together, requiring the use of anticoagulant and antiplatelet drugs. The study aims to compare the benefits and risks of two treatment strategies to address concerns about bleeding and cardiovascular events in these patients. Participants will be randomly assigned to one of two groups. The experimental group will receive full-dose anticoagulant therapy alone, stopping antiplatelet therapy. The control group will continue combined full-dose anticoagulant and antiplatelet therapies, including aspirin or clopidogrel. Anticoagulant treatment will be given according to international guidelines for deep vein thrombosis (DVT) or pulmonary embolism (PE), and treatment duration will be up to 12 months. During the study, participants will be monitored for clinically relevant bleeding, recurrent VTE, and major adverse ischemic cardiovascular and cerebrovascular events (MACCE). Researchers will evaluate safety and effectiveness across these outcomes at the end of the treatment period. Secondary measures include non-major bleeding, arterial events, and VTE complications. The study involves regular assessments over up to one year to determine which treatment strategy offers the best overall clinical benefit.
CONDITIONS
Brief Title
Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Adults with acute symptomatic proximal deep-vein thrombosis or pulmonary embolism
- Indication for full-dose anticoagulant therapy for at least 3 months
- Prescribed antiplatelet therapy for secondary prevention of atherosclerotic cardiovascular disease at VTE diagnosis
- Life expectancy over 3 months
- Affiliated with social security
You will not qualify if you...
- Unable to provide informed consent
- Active bleeding or high bleeding risk contraindicating anticoagulant treatment
- Systolic blood pressure over 180 mm Hg or diastolic over 110 mm Hg
- Anticoagulation treatment started more than 5 days before randomization
- Active pregnancy, expected pregnancy, or no effective contraception
- Isolated distal deep vein thrombosis
- Antiplatelet therapy prescribed for primary prevention only
- Indication to maintain dual-antiplatelet therapy
- Triple positive antiphospholipid syndrome with arterial thrombosis
- Major cardiovascular event in past 12 months or cerebrovascular/peripheral arterial event in past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive full-dose anticoagulant therapy alone or combined with antiplatelet therapy according to their assigned treatment strategy.
Regular visits as per investigator's discretion during treatment
Trial Site Locations
Total: 28 locations
1
CHU Amiens
Amiens, France
Actively Recruiting
2
CHU Angers
Angers, France
Actively Recruiting
3
CHU Besançon - Hôpital Jean Minjoz
Besançon, France
Actively Recruiting
4
CHRU Brest - Hôpital la Cavale Blanche
Brest, France
Actively Recruiting
5
Clinique du Parc - Castelnau-le -lez
Castelnau-le-Lez, France
Actively Recruiting
6
CHU Clermont-Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand, France
Actively Recruiting
7
CHU Dijon
Dijon, France
Actively Recruiting
8
CH le Corbusier - Firminy
Firminy, France
Actively Recruiting
9
CHU Grenoble - Hôpital la Tronche
Grenoble, France
Actively Recruiting
10
CH Le Puy - Hôpital Emile Roux
Le Puy-en-Velay, France
Actively Recruiting
11
CHU Limoges
Limoges, France
Actively Recruiting
12
HCL - Hôpital Edouard Herriot
Lyon, France
Actively Recruiting
13
HCL - Lyon Sud
Lyon, France
Actively Recruiting
14
APHM - Hôpital la Timone
Marseille, France
Actively Recruiting
15
CH du Forez - Montbrison
Montbrison, France
Actively Recruiting
16
CHU Montpellier
Montpellier, France
Actively Recruiting
17
CHU Nancy - Hôpitaux de Brabois
Nancy, France
Actively Recruiting
18
CHU Nantes - Hôpital Hôtel-Dieu
Nantes, France
Actively Recruiting
19
CHU de Nice - Hôpital Pasteur
Nice, France
Actively Recruiting
20
APHP - Hôpital Bicêtre
Paris, France
Actively Recruiting
21
APHP - Hôpital Européen Georges Pompidou HEGP
Paris, France
Actively Recruiting
22
APHP - Hôpital Louis Mourier
Paris, France
Actively Recruiting
23
CHU Rouen
Rouen, France
Actively Recruiting
24
CHU Saint-Etienne
Saint-Etienne, France
Actively Recruiting
25
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, France
Actively Recruiting
26
CH Toulon - Hôpital Sainte Musse
Toulon, France
Actively Recruiting
27
CHU Toulouse - Hôpital de Rangueil
Toulouse, France
Actively Recruiting
28
CHU Tours
Tours, France
Actively Recruiting
Research Team
L
Laurent BERTOLETTI, MD PhD
C
Carine LABRUYERE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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