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Anticoagulation therapy for heart-related blood clots

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

Phase 3 Interventional Centre Hospitalier Universitaire de Nīmes · NCT05825573

This study is testing whether a new type of blood thinner works better than a traditional one for patients with heart-related blood clots to see if it can help them stay safe and healthy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment340 (estimated)
Ages18 Years and up
SexAll
SponsorCentre Hospitalier Universitaire de Nīmes Academic / other
Locations35 sites (Angers and 34 other locations)
Trial IDNCT05825573 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of direct oral anticoagulants compared to vitamin K antagonists in patients with non-device-related intracardiac thrombus. The study aims to address the high risk of systemic embolism and mortality associated with these thrombi, particularly in patients with impaired left ventricular function following ST-segment elevation myocardial infarction or dilated cardiomyopathy. Participants will be anticoagulant naïve and will be monitored for safety and efficacy over a one-year follow-up period. The trial seeks to provide evidence-based recommendations for anticoagulation therapy in this specific clinical setting.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with non-device-related intracardiac thrombus who have not received anticoagulation therapy for at least three months.

Not a fit: Patients with active internal bleeding, recent major bleeding events, or severe disabling strokes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes and reduce the risk of embolism and mortality in patients with intracardiac thrombus.

How similar studies have performed: While there is limited randomized data specifically for intracardiac thrombus, the use of direct oral anticoagulants has shown success in other clinical settings, suggesting potential for positive outcomes in this trial.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Angers and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Intracardiac ThrombusSTEMIHeart Failureanticoagulation therapydirect oral anticoagulantstrokeacute coronary syndromeembolism
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.