Anticoagulation Therapy in Non-device-related Intra-cardiac Thrombus

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

340

Participants

Timeline

Start Date

May 15, 2023

Primary Completion Date

February 5, 2025

Study Completion Date

February 28, 2026

Conditions
Intracardiac ThrombusSTEMIHeart Failure
Interventions
DRUG

Vitamin K antagonist

VKA study medications (Warfarin, Fluindione and Acenocoumarol) will be prescribed and supplied in the usual setting of patient care with respect of the international guidelines and recommended dose protocols and will not be specifically supplied for the trial. Anticoagulant treatment will be prescribed for 6 months. The recommended INR target will be \[2-3\] and \[2-2.5\] for patients treated with concomitant antiplatelet therapy. Biological monitoring will be performed at discretion of physicians as usual care.

DRUG

Direct oral anticoagulant

DOA study medications (Apixaban, Rivaroxaban and Dabigatran) will be prescribed and supplied in the usual setting of patient care and will not be specifically supplied for the trial. The usual doses of DOA will be prescribed: dabigatran 150mg twice a day, apixaban 5mg twice a day and rivaroxaban 20mg once a day. The adjusted doses (dabigatran 110mg twice a day, apixaban 2.5mg twice a day and rivaroxaban 15mg once a day) will be prescribed according to clinical practice treatment guidelines.

Trial Locations (35)

26000

Centre Hopistalier de Valence, Valence

56000

Ch Bretagne Atlantique, Vannes

89000

Ch Auxerre, Auxerre

Unknown

CHU Angers, Angers

Ch Avignon, Avignon

CH Bastia, Bastia

Hôpital Cardiologique du Haut Lévêque, Bordeaux

CHU Brest, Brest

CH Chartres, Chartres

CHU Gabriel Montpied, Clermont-Ferrand

CH Compiègne Noyon, Compiègne

Hôpital Privé Dijon Bourgogne, Dijon

Groupe Hospitalier Mutualiste, Grenoble

CHU Lille, Lille

CHU Limoges, Limoges

Hôpital Cardiovasculaire Louis Pradel, Lyon

AP-HM CHU La Timone, Marseille

CHR Metz-Thionville, Metz

CHU Arnaud de Villeneuve, Montpellier

Clinique du Millenaire, Montpellier

CHU Nantes, Nantes

CHU Nice, Nice

CHU de Nimes, Nîmes

AP-HP CHU Bichat, Paris

AP-HP CHU Lariboisière, Paris

Ap-Hp Hegp, Paris

AP-HP Hopital Ambroise Paré, Paris

CHU Pitié-Salpêtrière, Paris

CH Francois Mitterand, Pau

CHU Poitiers, Potiers

CHU Rennes, Rennes

Centre Cardiologique du Nord, Saint-Denis

CHU Strasbourg, Strasbourg

CHU Toulouse, Toulouse

CHU La réunion NORD, Saint-Denis

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Nīmes

OTHER