- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05028777
Cohorte de patients atteints de thrombus ventriculaire gauche : prise en charge et résultats à l'ère des anticoagulants oraux directs (LV-Thrombus)
The investigators' primary objective is to assess whether a difference in the occurrence of bleeding events exist between patients with LVT treated with DOACs as compared to those treated with VKAs.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Left ventricular thrombus (LVT) is a well-known complication of left ventricle (LV) systolic dysfunction that can be seen in acute systolic dysfunction, i.e. induced by an acute myocardial infarction (AMI) or Takotsubo cardiomyopathy, and in chronic heart failure with reduced ejection fraction (HFrEF), whatever the cause.
Improvements in the management of AMI, particularly with the implementation of primary percutaneous coronary intervention (PCI), have led to a striking reduction in the occurrence of LVT in patients with AMI from about 30% in the thrombolytic era to about 4% nowadays, according to echocardiographic assessment. On the other hand prognosis of patients with LVT didn't change over time: mortality and risk of embolic events associated with this condition are still high.
A limited amount of evidence shows that oral anticoagulation is associated in the majority of patients with both resolution of LVT and reduction in ischemic events. This benefit comes at the cost of bleeding complications, which have been demonstrated to impact on mortality, especially in patients after AMI receiving an oral anticoagulant on top of a dual antiplatelet therapy (so-called triple antithrombotic therapy).
Current European and American guidelines on treatment of myocardial infarction with ST-elevation do not make strong recommendations for the management of LVT, whereas guidelines on treatment of heart failure do not give any. The European Society of Cardiology recommends an anticoagulation treatment for up to 6 months from diagnosis in case of LVT thrombus after AMI and the decision to continue the therapy after 6 months should be taken on the basis of echocardiographic follow-up (class IIa level of evidence C). The American College of Cardiology and American Heart Association (AHA) gives a similar recommendation (IIaC), however specifically mentioning vitamin K antagonists (VKAs) and a target INR (international normalized ratio) 2.0-2.5 for 3 months on top of dual antiplatelet therapy (DAPT). They also propose to consider an anticoagulant therapy for patients with severe anterior wall motion after STEMI but without LVT (IIbC). The AHA and American Stroke Association published in 2014 their last recommendations for secondary stroke prevention, which are in line with the above mentioned guidelines. Direct oral anticoagulants (DOACs) are mentioned as an alternative to VKAs (IIbC).
All guidelines agree that DOACs for LVT treatment cannot be recommended as first-line therapy because of the scarce evidence, based on case reports small case series and only one large retrospective study (RED VELVT study, published on April 22, 2020).
However, in clinical practice because of the establishment of DOACs over VKAs as first-line therapy to prevent embolic events in patients with atrial fibrillation, those are prescribed off-label to a significant number of patients with LVT. DOACs, as compared to VKAs, showed a greater efficacy regarding prevention of ischemic and hemorrhagic stroke and systemic embolic events in atrial fibrillation, but an increased risk of gastrointestinal bleedings.
The pathophysiology of thrombus formation in a left ventricle with regional wall motion abnormalities and in left atrium with atrial fibrillation is very similar and it implies a blood stasis as main mechanism. Thus one could expect that DOACs, which have been demonstrated to be superior to VKAs in term of prevention of embolic events in atrial fibrillation, have a similar effect on treatment of LVT. However, the first large retrospective study including 541 patients with LVT, of which 421 treated with anticoagulation showed an increased risk of embolic events at 1 year among patients with LVT treated with DOACs as compared to those on VKAs; occurrence of bleeding events was not reported.
Beside the above mentioned uncertainty concerning duration and type of treatment (VKAs versus DOACs) in LVT, there are also some issues concerning the imaging modality used for the diagnosis of LVT. Several studies comparing the diagnostic performance of transthoracic echocardiography (TTE) versus cardiac magnetic resonance (CMR) showed a roughly 30% sensitivity of TTE when taking delayed-enhancement CMR (DE-CMR) as gold standard. With the growing use of CMR, an increasing number of patients are diagnosed with small left ventricular thrombi, which would have been missed in usual clinical practice and which seem to be associated with an embolic risk similar to thrombi detected by TTE.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Bern, Suisse, 3010
- Department of Cardiology, University Hospital Bern
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
This is an observational, retrospective and prospective, monocentric study including all patients diagnosed with left ventricular thrombus through different imaging modalities (echocardiography, CT or MRI)
La description
Inclusion Criteria:
- Patients at least 18 years old at enrolment
- With a LVT identified at echocardiography, MRI or CT between January 1st, 2013 and July 31st, 2020
- Treated at least once at the Inselspital or in another site of the Insel Gruppe
- Able to provide a written informed consent
Exclusion Criteria:
- Documented refusal
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: OTHER
Cohortes et interventions
Groupe / Cohorte |
|---|
|
Patients diagnosed with left ventricular thrombus
All patients diagnosed with left ventricular thrombus through different imaging modalities (echocardiography, CT or MRI) and who have been diagnosed and/or treated at the Inselspital or another site of the Insel Gruppe. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The occurrence at 1 year of bleeding
Délai: 1 year
|
Primary combined endpoint includes the occurrence at 1 year of bleeding BARC (Bleeding Academic Research) Consortium type 2, 3 or 5. |
1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of patients with arterial systemic embolic event
Délai: 1, 2 and 5 years
|
Combined endpoint of arterial systemic embolic event, including ischemic stroke, myocardial infarction, peripheral embolism (e.g. splenic infarction, renal infarction, bowel infarction, acute embolic limb ischemia) at 1, 2 and 5 years. |
1, 2 and 5 years
|
|
Rate of patients with ischemic stroke
Délai: 1, 2 and 5 years
|
Each arterial systemic embolic event considered separately at 1, 2 and 5 years |
1, 2 and 5 years
|
|
Rate of patients with myocardial infraction
Délai: 1, 2 and 5 years
|
Each arterial systemic embolic event considered separately at 1, 2 and 5 years |
1, 2 and 5 years
|
|
Rate of patients with peripheral embolism
Délai: 1, 2 and 5 years
|
Each arterial systemic embolic event considered separately at 1, 2 and 5 years |
1, 2 and 5 years
|
|
Rate of patients with transient ischemic attack
Délai: 1, 2 and 5 years
|
Transient ischemic attack at 1, 2 and 5 years |
1, 2 and 5 years
|
|
Rate of patients with pulmonary embolism
Délai: 1, 2 and 5 years
|
Pulmonary embolism at 1, 2 and 5 years |
1, 2 and 5 years
|
|
All-cause mortality
Délai: 1, 2 and 5 years
|
All-cause mortality at 1, 2 and 5 year(s) |
1, 2 and 5 years
|
|
LVT size/resolution
Délai: 5 years
|
LVT size/resolution at follow-up imaging |
5 years
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Christoph Gräni, Prof. PHD, Department of Cardiology, University Hospital Bern
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2020-02187
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .