RecruitingPhase 3NCT05627375

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


Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrollment

1,400 participants

Start Date

Aug 16, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating the best combination of blood-thinning medications for people who develop an acute blood clot (venous thromboembolism, or VTE) while already taking antiplatelet medications for heart or vascular disease. When these patients get a DVT or pulmonary embolism, it's unclear whether they should stop the antiplatelet drug, continue it alongside anticoagulation, or adjust one of the treatments. This trial aims to find the safest and most effective combination. You may be eligible if: - You are 18 years of age or older - You have been diagnosed with an acute deep vein thrombosis (DVT) in a major leg vein or a pulmonary embolism (PE) - You need at least 3 months of full anticoagulation therapy - You are already taking antiplatelet medications (such as aspirin or clopidogrel) for a cardiovascular condition like heart disease or stroke prevention - You have a life expectancy greater than 3 months You may NOT be eligible if: - You have active or high-risk bleeding that makes anticoagulation unsafe - Your blood pressure is severely elevated (above 180/110 mmHg) - You have been on anticoagulation for more than 5 days before enrollment - You are pregnant or planning to become pregnant - You only have an isolated clot in a small distal vein - You are taking antiplatelet drugs for primary (not secondary) cardiovascular prevention - You have had a major heart attack, stroke, or vascular event in the past 6–12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFull-dose anticoagulant therapy (AC)

Anticoagulant (AC) therapy: at the investigator's discretion in accordance with international recommendations for the management of DVT/PE

DRUGAntiplatelet therapy (AP)

Aspirin (at a daily dose ≤100 mg) or Clopidogrel (at a daily dose ≤75mg)


Locations(28)

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

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NCT05627375


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