Intracardiac ThrombusPhase 3ARGONAUTNCT05825573
Anticoagulation Therapy in Non-device-related Intra-cardiac Thrombus
A Phase 3 study testing Vitamin K antagonist and Direct oral anticoagulant in people with Intracardiac Thrombus and STEMI, run by Centre Hospitalier Universitaire de Nīmes at 35 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracardiac Thrombus, STEMI, Heart Failure
- What is being tested?
- Vitamin K antagonist and Direct oral anticoagulant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 35 sitesin 2 countries
- Study dates
- 15 May 2023to Feb 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
France34 sites
CHU Angers
Angers
Ch Auxerre
Auxerre, 89000
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
Centre Hopistalier de Valence
Valence, 26000
Ch Bretagne Atlantique
Vannes, 56000
About this study
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
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.
- Conditions
- Intracardiac Thrombus, STEMI, Heart Failure
- Being tested
- Vitamin K antagonist, Direct oral anticoagulant
- Keywords
- anticoagulation therapy, direct oral anticoagulant, stroke, acute coronary syndrome, embolism
- Medical subject headings
- ST Elevation Myocardial Infarction, Heart Failure, Stroke, Acute Coronary Syndrome, Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K antagonistDrug
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.
Direct oral anticoagulantDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Reference treatment | Active comparator | Not described Receives: Drug: Vitamin K antagonist |
| Direct Oral Anticoagulant | Experimental | Not described Receives: Drug: Direct oral anticoagulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (22)
All cause death between groups
Any death documented during the follow-up independently of cause of death
Measured: 6 months
All cause death between groups
Any death documented during the follow-up independently of cause of death
Measured: 12 months
Myocardial infarction occurrence between groups
All non-fatal MI, excluding MI type 3, which will be captured separately as death
Measured: 6 months
Myocardial infarction occurrence between groups
All non-fatal MI, excluding MI type 3, which will be captured separately as death
Measured: 12 months
Stroke occurrence between groups
Classified as Transient ischemic attack (TIA), Ischemic Stroke, Haemorrhagic Stroke and Undetermined Stroke
Measured: 6 months
Stroke occurrence between groups
Classified as Transient ischemic attack (TIA), Ischemic Stroke, Haemorrhagic Stroke and Undetermined Stroke
Measured: 12 months
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
Measured: 6 months
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
Measured: 12 months
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
Measured: 6 months
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
Measured: 12 months
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
Measured: 6 months
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
Measured: 12 months
Clinically relevant bleedings between groups
International Bleeding Academic Research Consortium (BARC) types 2 to 5
Measured: 6 months
Clinically relevant bleedings between groups
International Bleeding Academic Research Consortium (BARC) types 2 to 5
Measured: 12 months
Systemic embolism between groups
defined by the composite of stroke, embolic myocardial infarction, peripheral artery occlusion and acute pulmonary embolism
Measured: 6 months
Systemic embolism between groups
defined by the composite of stroke, embolic myocardial infarction, peripheral artery occlusion and acute pulmonary embolism
Measured: 12 months
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.
Measured: 6 months
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.
Measured: 12 months
Total thrombus recurrence between groups
Recurrence of thrombus on cardiac imaging control following a total thrombus regression during the follow-up
Measured: 6 months
Total thrombus recurrence between groups
Recurrence of thrombus on cardiac imaging control following a total thrombus regression during the follow-up
Measured: 12 months
Major bleedings between groups
International Bleeding Academic Research Consortium (BARC) types 3 to 5
Measured: 6 months
Major bleedings between groups
International Bleeding Academic Research Consortium (BARC) types 3 to 5
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start15 May 2023
- Primary completion5 Feb 2025
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracardiac ThrombusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- benoit.lattuca@chu-nimes.fr Lattuca, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825573
- Sponsor's protocol ID
- PHRC-N/2020/BL-01
- Acronym
- ARGONAUT
- Status last verified
- Feb 2026
- First submitted
- 11 Apr 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32273033
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05825573
- Acronym / sponsor ID
- ARGONAUT / PHRC-N/2020/BL-01
- Conditions
- Intracardiac Thrombus, STEMI, Heart Failure
- Keywords
- anticoagulation therapy, direct oral anticoagulant, stroke, acute coronary syndrome, embolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- Feb 2026 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference treatment | Active comparator | Drug: Vitamin K antagonist |
| Direct Oral Anticoagulant | Experimental | Drug: Direct oral anticoagulant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K antagonistVKA 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 | Reference treatment |
| Direct oral anticoagulantDOA 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. | Drug | Direct Oral Anticoagulant |
Primary outcome
Net clinical benefit of DOA in comparison to VKA in patients with intra-cardiac thrombus
Time frame: 6 months
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)
22 secondary outcomes
All cause death between groups
Time frame: 6 months
All cause death between groups
Time frame: 12 months
Myocardial infarction occurrence between groups
Time frame: 6 months
Myocardial infarction occurrence between groups
Time frame: 12 months
Stroke occurrence between groups
Time frame: 6 months
Stroke occurrence between groups
Time frame: 12 months
Acute peripheral emboli occurrence between groups
Time frame: 6 months
Acute peripheral emboli occurrence between groups
Time frame: 12 months
Acute pulmonary embolism occurrence between groups
Time frame: 6 months
Acute pulmonary embolism occurrence between groups
Time frame: 12 months
Thrombus persistence between groups
Time frame: 6 months
Thrombus persistence between groups
Time frame: 12 months
Clinically relevant bleedings between groups
Time frame: 6 months
Clinically relevant bleedings between groups
Time frame: 12 months
Systemic embolism between groups
Time frame: 6 months
Systemic embolism between groups
Time frame: 12 months
Cardiovascular death between groups
Time frame: 6 months
Cardiovascular death between groups
Time frame: 12 months
Total thrombus recurrence between groups
Time frame: 6 months
Total thrombus recurrence between groups
Time frame: 12 months
Major bleedings between groups
Time frame: 6 months
Major bleedings between groups
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 32273033Lattuca 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
benoit.lattuca@chu-nimes.fr Lattuca principal investigator
CHU Nimes
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin K antagonist and Direct oral anticoagulant in people with Intracardiac Thrombus and STEMI, run by Centre Hospitalier Universitaire de Nīmes at 35 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in France, Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net clinical benefit of DOA in comparison to VKA in patients with intra-cardiac thrombus (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05825573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.