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Anticoagulation Therapy in Non-device-related Intra-cardiac Thrombus (ARGONAUT)

Primary Purpose

Intracardiac Thrombus, STEMI, Heart Failure

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vitamin K antagonist
Direct oral anticoagulant
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracardiac Thrombus focused on measuring anticoagulation therapy, direct oral anticoagulant, stroke, acute coronary syndrome, embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient with a non-device related intra-cardiac thrombus (all localizations in the four cavities) diagnosed by echocardiography, cardiac CT-scanner or cardiac magnetic resonance imaging independently of underlying heart disease. Anticoagulant naïve patient for at least 3 months Patient affiliated to a health insurance program Patient that accepted not to participate in other studies involving a study medication until the one-year follow-up visit. Registries and studies not involving a study drug are allowed. Patient that signed the consent form Exclusion Criteria: Active internal bleeding or recent (< 6 months) major bleeding event requiring surgical procedure or transfusion History of intracranial, intraocular, spinal bleeding or known intracranial neoplasm, arteriovenous malformation, or aneurysm Severe, disabling stroke (modified Rankin score of 4 to 5, inclusive) within 3 months Planned invasive procedure with potential for uncontrolled bleeding Impaired hemostasis such as known International Normalized Ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/μL) Severe chronic renal failure (creat. clearance<30ml/min) Known significant liver disease Device related thrombus (mechanical valve prosthesis, left atrial appendage or septal closure devices, pacemaker leads) Patients with mechanical valve prosthesis Cardiogenic shock Pregnancy or breast-feeding patient Known allergy or hypersensitivity to VKA or DOA drugs Inability or unwillingness to comply with study-related procedures Participation in another clinical research protocol with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrolment in this trial (participation in a trial of routine care is authorized at the same time) Patient under tutorship or curatorship

Sites / Locations

  • CHU AngersRecruiting
  • CH de la Région Annecienne
  • Ch AvignonRecruiting
  • CH Bastia
  • Hôpital Cardiologique du Haut LévêqueRecruiting
  • CHU Brest
  • CH ChartresRecruiting
  • CHU Gabriel MontpiedRecruiting
  • CH Compiègne Noyon
  • Hôpital Privé Dijon BourgogneRecruiting
  • Groupe Hospitalier MutualisteRecruiting
  • CHU LilleRecruiting
  • CHU LimogesRecruiting
  • Hôpital Cardiovasculaire Louis PradelRecruiting
  • AP-HM CHU La Timone
  • CHR Metz-ThionvilleRecruiting
  • CHU Arnaud de VilleneuveRecruiting
  • Clinique du MillenaireRecruiting
  • CHU Nantes
  • CHU NiceRecruiting
  • CHU de NimesRecruiting
  • AP-HP CHU Bichat
  • AP-HP CHU Lariboisière
  • Ap-Hp HegpRecruiting
  • AP-HP Hopital Ambroise Paré
  • CHU Pitié-SalpêtrièreRecruiting
  • CH Francois MitterandRecruiting
  • CH Joffre Perpignan
  • CHU PoitiersRecruiting
  • CHU Rennes
  • Centre Cardiologique du Nord
  • CHU Strasbourg
  • CHU ToulouseRecruiting
  • CHU La réunion NORDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Reference treatment

Direct Oral Anticoagulant

Arm Description

Outcomes

Primary Outcome Measures

Net clinical benefit of DOA in comparison to VKA in patients with intra-cardiac thrombus
Composite endpoint of all-cause death, myocardial infarction, stroke, acute peripheral emboli, acute pulmonary embolism, thrombus persistence and clinically relevant bleedings (BARC 2 to 5 bleedings)

Secondary Outcome Measures

All cause death between groups
Any death documented during the follow-up independently of cause of death
All cause death between groups
Any death documented during the follow-up independently of cause of death
Myocardial infarction occurrence between groups
All non-fatal MI, excluding MI type 3, which will be captured separately as death
Myocardial infarction occurrence between groups
All non-fatal MI, excluding MI type 3, which will be captured separately as death
Stroke occurrence between groups
Classified as Transient ischemic attack (TIA), Ischemic Stroke, Haemorrhagic Stroke and Undetermined Stroke
Stroke occurrence between groups
Classified as Transient ischemic attack (TIA), Ischemic Stroke, Haemorrhagic Stroke and Undetermined Stroke
Acute peripheral emboli occurrence between groups
All acute artery occlusion (limb, renal or digestive artery occlusion confirmed by clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing
Acute peripheral emboli occurrence between groups
All acute artery occlusion (limb, renal or digestive artery occlusion confirmed by clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing
Acute pulmonary embolism occurrence between groups
Defined as partial or complete occlusion of pulmonary artery or one of its branch confirmed by consistent clinical history and supported by evidence of embolism from surgical specimens, autopsy, angiography or vascular imaging in accordance to international guidelines
Acute pulmonary embolism occurrence between groups
Defined as partial or complete occlusion of pulmonary artery or one of its branch confirmed by consistent clinical history and supported by evidence of embolism from surgical specimens, autopsy, angiography or vascular imaging in accordance to international guidelines
Thrombus persistence between groups
Defined by cardiac imaging (echocardiography, contrast echocardiography, cardiac CT scan or cardiac MRI) as an increased thrombus dimension, a stable thrombus, or a partial thrombus regression
Thrombus persistence between groups
Defined by cardiac imaging (echocardiography, contrast echocardiography, cardiac CT scan or cardiac MRI) as an increased thrombus dimension, a stable thrombus, or a partial thrombus regression
Clinically relevant bleedings between groups
International Bleeding Academic Research Consortium (BARC) types 2 to 5
Clinically relevant bleedings between groups
International Bleeding Academic Research Consortium (BARC) types 2 to 5
Systemic embolism between groups
defined by the composite of stroke, embolic myocardial infarction, peripheral artery occlusion and acute pulmonary embolism
Systemic embolism between groups
defined by the composite of stroke, embolic myocardial infarction, peripheral artery occlusion and acute pulmonary embolism
Cardiovascular death between groups
Any death due to myocardial infarction, ischemic and haemorrhagic stroke, systemic embolism, sudden death, low-output failure, fatal arrhythmia, cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other cardiovascular cause. All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided.
Cardiovascular death between groups
Any death due to myocardial infarction, ischemic and haemorrhagic stroke, systemic embolism, sudden death, low-output failure, fatal arrhythmia, cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other cardiovascular cause. All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided.
Total thrombus recurrence between groups
Recurrence of thrombus on cardiac imaging control following a total thrombus regression during the follow-up
Total thrombus recurrence between groups
Recurrence of thrombus on cardiac imaging control following a total thrombus regression during the follow-up
Major bleedings between groups
International Bleeding Academic Research Consortium (BARC) types 3 to 5
Major bleedings between groups
International Bleeding Academic Research Consortium (BARC) types 3 to 5

Full Information

First Posted
April 11, 2023
Last Updated
September 7, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT05825573
Brief Title
Anticoagulation Therapy in Non-device-related Intra-cardiac Thrombus
Acronym
ARGONAUT
Official Title
Anticoagulant Regimens Given to Achieve Thrombus Regression and Reduce Clinical Outcomes Among Patients With Non Device-related Intra-cardiac Thrombus: a Randomized Assessment Under Direct Oral Anticoagulant and Vitamin-k Antagonist Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Left ventricular thrombus is found in 10 to 25% of patients with impaired left ventricular function following ST-segment elevation myocardial infarction and up to 20% in dilated cardiomyopathy in observational studies. Likewise, the incidence of atrial thrombus among atrial fibrillation patients treated by vitamin K antagonist (VKA) is between 0.25% and 7%. Despite anticoagulant therapy, intra-cardiac thrombus remains a severe complication associated with a high risk of systemic embolism and subsequent mortality but also bleeding events related to the anticoagulation therapy. The class of non-vitamin K antagonist direct oral anticoagulant (DOA) has emerged in the last decades and has systematically surpassed VKA in the different clinical settings by providing at minimum a similar efficacy and a better safety profile. In the absence of randomized study in the specific clinical setting of intracardiac thrombus, international Guidelines recommend, on the basis of expert opinion, the use of VKA for at least 3 to 6 months in case of left ventricular thrombus and there is no specific recommendation for thrombus management from other cardiac localizations. In comparison to VKA, the easier management and the large evidence of better safety of DOA make it an interesting anticoagulant strategy. Data for left ventricule thrombosis treatment are limited and only supported by observational cohorts. However, these recent cohorts have shown promising data in this indication reporting similar thrombus regression following DOA in comparison to VKA and similar ischemic outcomes although no head-to-head comparison would be powered. As a consequence, the multicentric randomized ARGONAUT trial aims to confirm these results and evaluate the impact of DOA compared to VKA on thrombus regression and clinical outcomes among patients with intracardiac thrombus, regardless of the thrombus localization and any underlying heart disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracardiac Thrombus, STEMI, Heart Failure
Keywords
anticoagulation therapy, direct oral anticoagulant, stroke, acute coronary syndrome, embolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reference treatment
Arm Type
Active Comparator
Arm Title
Direct Oral Anticoagulant
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vitamin K antagonist
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Direct oral anticoagulant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Net clinical benefit of DOA in comparison to VKA in patients with intra-cardiac thrombus
Description
Composite endpoint of all-cause death, myocardial infarction, stroke, acute peripheral emboli, acute pulmonary embolism, thrombus persistence and clinically relevant bleedings (BARC 2 to 5 bleedings)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
All cause death between groups
Description
Any death documented during the follow-up independently of cause of death
Time Frame
6 months
Title
All cause death between groups
Description
Any death documented during the follow-up independently of cause of death
Time Frame
12 months
Title
Myocardial infarction occurrence between groups
Description
All non-fatal MI, excluding MI type 3, which will be captured separately as death
Time Frame
6 months
Title
Myocardial infarction occurrence between groups
Description
All non-fatal MI, excluding MI type 3, which will be captured separately as death
Time Frame
12 months
Title
Stroke occurrence between groups
Description
Classified as Transient ischemic attack (TIA), Ischemic Stroke, Haemorrhagic Stroke and Undetermined Stroke
Time Frame
6 months
Title
Stroke occurrence between groups
Description
Classified as Transient ischemic attack (TIA), Ischemic Stroke, Haemorrhagic Stroke and Undetermined Stroke
Time Frame
12 months
Title
Acute peripheral emboli occurrence between groups
Description
All acute artery occlusion (limb, renal or digestive artery occlusion confirmed by clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing
Time Frame
6 months
Title
Acute peripheral emboli occurrence between groups
Description
All acute artery occlusion (limb, renal or digestive artery occlusion confirmed by clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing
Time Frame
12 months
Title
Acute pulmonary embolism occurrence between groups
Description
Defined as partial or complete occlusion of pulmonary artery or one of its branch confirmed by consistent clinical history and supported by evidence of embolism from surgical specimens, autopsy, angiography or vascular imaging in accordance to international guidelines
Time Frame
6 months
Title
Acute pulmonary embolism occurrence between groups
Description
Defined as partial or complete occlusion of pulmonary artery or one of its branch confirmed by consistent clinical history and supported by evidence of embolism from surgical specimens, autopsy, angiography or vascular imaging in accordance to international guidelines
Time Frame
12 months
Title
Thrombus persistence between groups
Description
Defined by cardiac imaging (echocardiography, contrast echocardiography, cardiac CT scan or cardiac MRI) as an increased thrombus dimension, a stable thrombus, or a partial thrombus regression
Time Frame
6 months
Title
Thrombus persistence between groups
Description
Defined by cardiac imaging (echocardiography, contrast echocardiography, cardiac CT scan or cardiac MRI) as an increased thrombus dimension, a stable thrombus, or a partial thrombus regression
Time Frame
12 months
Title
Clinically relevant bleedings between groups
Description
International Bleeding Academic Research Consortium (BARC) types 2 to 5
Time Frame
6 months
Title
Clinically relevant bleedings between groups
Description
International Bleeding Academic Research Consortium (BARC) types 2 to 5
Time Frame
12 months
Title
Systemic embolism between groups
Description
defined by the composite of stroke, embolic myocardial infarction, peripheral artery occlusion and acute pulmonary embolism
Time Frame
6 months
Title
Systemic embolism between groups
Description
defined by the composite of stroke, embolic myocardial infarction, peripheral artery occlusion and acute pulmonary embolism
Time Frame
12 months
Title
Cardiovascular death between groups
Description
Any death due to myocardial infarction, ischemic and haemorrhagic stroke, systemic embolism, sudden death, low-output failure, fatal arrhythmia, cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other cardiovascular cause. All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided.
Time Frame
6 months
Title
Cardiovascular death between groups
Description
Any death due to myocardial infarction, ischemic and haemorrhagic stroke, systemic embolism, sudden death, low-output failure, fatal arrhythmia, cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other cardiovascular cause. All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided.
Time Frame
12 months
Title
Total thrombus recurrence between groups
Description
Recurrence of thrombus on cardiac imaging control following a total thrombus regression during the follow-up
Time Frame
6 months
Title
Total thrombus recurrence between groups
Description
Recurrence of thrombus on cardiac imaging control following a total thrombus regression during the follow-up
Time Frame
12 months
Title
Major bleedings between groups
Description
International Bleeding Academic Research Consortium (BARC) types 3 to 5
Time Frame
6 months
Title
Major bleedings between groups
Description
International Bleeding Academic Research Consortium (BARC) types 3 to 5
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with a non-device related intra-cardiac thrombus (all localizations in the four cavities) diagnosed by echocardiography, cardiac CT-scanner or cardiac magnetic resonance imaging independently of underlying heart disease. Anticoagulant naïve patient for at least 3 months Patient affiliated to a health insurance program Patient that accepted not to participate in other studies involving a study medication until the one-year follow-up visit. Registries and studies not involving a study drug are allowed. Patient that signed the consent form Exclusion Criteria: Active internal bleeding or recent (< 6 months) major bleeding event requiring surgical procedure or transfusion History of intracranial, intraocular, spinal bleeding or known intracranial neoplasm, arteriovenous malformation, or aneurysm Severe, disabling stroke (modified Rankin score of 4 to 5, inclusive) within 3 months Planned invasive procedure with potential for uncontrolled bleeding Impaired hemostasis such as known International Normalized Ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/μL) Severe chronic renal failure (creat. clearance<30ml/min) Known significant liver disease Device related thrombus (mechanical valve prosthesis, left atrial appendage or septal closure devices, pacemaker leads) Patients with mechanical valve prosthesis Cardiogenic shock Pregnancy or breast-feeding patient Known allergy or hypersensitivity to VKA or DOA drugs Inability or unwillingness to comply with study-related procedures Participation in another clinical research protocol with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrolment in this trial (participation in a trial of routine care is authorized at the same time) Patient under tutorship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benoit Lattuca
Phone
33 4 66 68 31 16
Email
benoit.lattuca@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
benoit.lattuca@chu-nimes.fr Lattuca
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice PRUNIER
Email
faprunier@chu-angers.fr
Facility Name
CH de la Région Annecienne
City
Annecy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Jost
Email
sjostturrillot@ch-annecygenevois.fr
Facility Name
Ch Avignon
City
Avignon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marine QUILLOT
Email
marine.quillot@gmail.com
Facility Name
CH Bastia
City
Bastia
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziad BOUERI
Phone
04 95 59 11 09
Email
ziad.boueri@ch-bastia.fr
Facility Name
Hôpital Cardiologique du Haut Lévêque
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard GERBAUD
Phone
06.88.54.09.15
Email
edouard.gerbaud@chu-bordeaux.fr
Facility Name
CHU Brest
City
Brest
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine GILARD
Email
martine.gilard@chu-brest.fr
Facility Name
CH Chartres
City
Chartres
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégoire RANGé
Email
grange@ch-chartres.fr
Facility Name
CHU Gabriel Montpied
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas COMBARET
Phone
04 73 75 44 49
Email
n_combaret@chu-clermontferrand.fr
Facility Name
CH Compiègne Noyon
City
Compiègne
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme Clerc
Phone
06 10 05 11 21
Email
j.clerc@ch-compiegnenoyon.fr
Facility Name
Hôpital Privé Dijon Bourgogne
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc LORGIS
Phone
03.80.29.55.81
Email
luc.lorgis@chu-dijon.fr
Facility Name
Groupe Hospitalier Mutualiste
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lea MARGERIT
Email
lea.margerit@avec.fr
Facility Name
CHU Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavien F VINCENT
Email
Flavien.vincent@chru-lille.fr
Facility Name
CHU Limoges
City
Limoges
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor ABOYANS
Email
vaboyans@live.fr
Facility Name
Hôpital Cardiovasculaire Louis Pradel
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Leboube
Email
simon.leboube@chu-lyon.fr
Facility Name
AP-HM CHU La Timone
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas CUISSET
Phone
04 91 38 59 75
Email
thomas.cuisset@ap-hm.fr
Facility Name
CHR Metz-Thionville
City
Metz
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noura ZANNAD
Email
n.zannad@chr-metz-thionville.fr
Facility Name
CHU Arnaud de Villeneuve
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Leclercq
Phone
04 67 33 61 85
Email
f-leclercq@chu-montpellier.fr
Facility Name
Clinique du Millenaire
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guilhem MALCLES
Email
guilhem.malcles@gmail.com
Facility Name
CHU Nantes
City
Nantes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien PLESSIS
Email
Julien.PLESSIS@chu-nantes.fr
Facility Name
CHU Nice
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emile FERRARI
Email
ferrari.e@chu-nice.fr
Facility Name
CHU de Nimes
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
+33466684236
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Benoit Lattuca
Facility Name
AP-HP CHU Bichat
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégory DUCROCQ
Email
gregory.ducrocq@aphp.fr
Facility Name
AP-HP CHU Lariboisière
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Guillaume DILLINGER
Phone
01 49 95 81 91
Email
jean-guillaume.dillinger@aphp.fr
Facility Name
Ap-Hp Hegp
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne PUYMIRAT
Email
etienne.puymirat@aphp.fr
Facility Name
AP-HP Hopital Ambroise Paré
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie HAUGUEL-MOREAU
Phone
01 49 09 58 85
Email
mariehauguel@yahoo.fr
Facility Name
CHU Pitié-Salpêtrière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanne Silvain
Phone
0142162961
Email
johanne.silvain@aphp.fr
Facility Name
CH Francois Mitterand
City
Pau
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas DELARCHE
Phone
05 59 92 48 78
Email
n.delarche@wanadoo.fr
Facility Name
CH Joffre Perpignan
City
Perpignan
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre SULTAN
Email
pierre.sultan@ch-perpignan.fr
Facility Name
CHU Poitiers
City
Potiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire BOULETI
Phone
05 49 44 44 44
Email
claire.bouleti@gmail.com
Facility Name
CHU Rennes
City
Rennes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent AUFFRET
Email
Vincent.AUFFRET@chu-rennes.fr
Facility Name
Centre Cardiologique du Nord
City
Saint-Denis
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David ATTIAS
Phone
01.49.33.48.72
Email
d.attias@ccn.fr
Facility Name
CHU Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick OLHMANN
Email
patrick.ohlmann@chru-strasbourg.fr
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaut LHERMUSIER
Phone
05 61 32 33 10
Email
lhermusier.t@chu-toulouse.fr
Facility Name
CHU La réunion NORD
City
Saint-Denis
Country
Réunion
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thiziri SI MOUSSI
Email
thiziri.simoussi@chu-reunion.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
32273033
Citation
Lattuca B, Bouziri N, Kerneis M, Portal JJ, Zhou J, Hauguel-Moreau M, Mameri A, Zeitouni M, Guedeney P, Hammoudi N, Isnard R, Pousset F, Collet JP, Vicaut E, Montalescot G, Silvain J; ACTION Study Group. Antithrombotic Therapy for Patients With Left Ventricular Mural Thrombus. J Am Coll Cardiol. 2020 Apr 14;75(14):1676-1685. doi: 10.1016/j.jacc.2020.01.057.
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Anticoagulation Therapy in Non-device-related Intra-cardiac Thrombus

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