Status:

RECRUITING

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

Lead Sponsor:

Centre Hospitalier Universitaire de Saint Etienne

Collaborating Sponsors:

Ministry of Health, France

Conditions:

Venous Thromboembolic Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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: ...

Detailed Description

Up to one third of VTE patients receive concomitant AP therapy, with conflicting results on patient outcomes. Concomitant therapy (AC+AP) has been associated with a higher risk of bleeding (up to 3-fo...

Eligibility Criteria

Inclusion 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 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:

  • 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

Key Trial Info

Start Date :

August 16 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2028

Estimated Enrollment :

1400 Patients enrolled

Trial Details

Trial ID

NCT05627375

Start Date

August 16 2023

End Date

December 1 2028

Last Update

March 18 2025

Active Locations (28)

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Page 1 of 7 (28 locations)

1

CHU Amiens

Amiens, France

2

CHU Angers

Angers, France

3

CHU Besançon - Hôpital Jean Minjoz

Besançon, France

4

CHRU Brest - Hôpital la Cavale Blanche

Brest, France