- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07644247
STudy of Aspirin Removal in Patients Supported by the Fully Magnetically Levitated CH-VAD Pump (STAR)
A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled STudy of Aspirin Removal in Patients Supported by the Fully Magnetically Levitated CH-VAD Pump (STAR Trial)
Aperçu de l'étude
Statut
Les conditions
- Accident vasculaire cérébral
- Thrombose
- Saignement
- Aspirine
- Thérapie antithrombotique
- Saignement gastro-intestinal lié au LVAD
- Thérapie antiplaquettaire
- DAVG
- Dispositif d'assistance ventriculaire
- Thrombose LVAD (dispositif d'assistance ventriculaire gauche)
- LVAD (Dispositif d'assistance ventriculaire gauche)
- Événement indésirable lié à l'hémocompatibilité
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- Phase 4
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kai Chen, Dr
- Numéro de téléphone: 13269333241
- E-mail: ck_2003@126.com
Sauvegarde des contacts de l'étude
- Nom: Zelin Yin
- Numéro de téléphone: 13321153733
- E-mail: zelin_0823@163.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
-
Study participants must meet all the following criteria:
- Age ≥18 years old;
- Implanted with the CH-VAD pump for advanced heart failure, and the CH-VAD pump is the first implanted left ventricular assist device;
- Able to understand the study purpose, voluntarily participate and sign the informed consent form, and willing to comply with the study procedures and follow-up requirements.
Exclusion Criteria:
-
Study participants meet any of the following criteria will be excluded:
- Requirement for additional temporary or permanent mechanical circulatory support after LVAD implantation;
- Requirement for physician-mandated antiplatelet therapy after implantation due to medical history, surgical history, concomitant surgical procedures, or other conditions, including mandated presence or absence of antiplatelet agent;
- Occurrence of primary endpoint events prior to randomization (within 2-7 days after implantation);
- Inability to take oral medications post-implant through 7 days;
- Known allergy to aspirin;
- Participation in another clinical investigation that may affect study outcome;
- Presence of other comorbid conditions, social or psychological conditions, or other conditions, in the investigator's opinion, that may affect participation in the study or compliance with follow-up requirements.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Placebo group
vitamin K antagonist with placebo
|
Warfarin (INR 2-3) with placebo
|
|
Comparateur actif: Aspirin group
vitamin K antagonist with aspirin
|
Warfarin (INR 2-3) with aspirin
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Survival free from major hemocompatibility-related adverse events at 12 months post-implantation
Délai: 12 months post implantation
|
Major hemocompatibility-related adverse events include stroke, suspected or confirmed pump thrombosis, peripheral arterial embolism, myocardial infarction, aortic root thrombosis, and non-surgical major bleeding. Note: Stroke includes ischemic stroke and hemorrhagic stroke. Non-surgical major bleeding is defined as major bleeding events occurring more than 14 days after implantation, including Type 3-5 bleeding events and intracranial hemorrhage that does not meet the definition of hemorrhagic stroke. |
12 months post implantation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Key Secondary Outcome: Incidence of major thromboembolic events at 12 months post-implantation
Délai: 12 months post implantation
|
Major thromboembolic events include ischemic stroke, suspected or confirmed pump thrombosis, peripheral arterial embolism, myocardial infarction, and aortic root thrombosis.
|
12 months post implantation
|
|
Incidence of non-surgical bleeding
Délai: 12 months post implantation
|
including non-surgical major bleeding and hemorrhagic stroke
|
12 months post implantation
|
|
Overall survival rate
Délai: 12 months post implantation
|
Overall survival rate
|
12 months post implantation
|
|
Incidence of stroke
Délai: 12 months post implantation
|
Including all stroke, hemorrhagic stroke, ischemic stroke, and disabling stroke
|
12 months post implantation
|
|
Incidence of pump thrombosis
Délai: 12 months post implantation
|
Including suspected pump thrombosis
|
12 months post implantation
|
|
Incidence of peripheral arterial embolism
Délai: 12 months post implantation
|
Incidence of peripheral arterial embolism
|
12 months post implantation
|
|
Incidence of myocardial infarction
Délai: 12 months post implantation
|
Incidence of myocardial infarction
|
12 months post implantation
|
|
Incidence of aortic root thrombosis
Délai: 12 months post implantation
|
Incidence of aortic root thrombosis
|
12 months post implantation
|
|
Incidence of bleeding
Délai: 12 months post implantation
|
Including major bleeding, gastrointestinal bleeding, and hemorrhagic stroke
|
12 months post implantation
|
|
Rehospitalization rate
Délai: 12 months post implantation
|
Rehospitalization rate
|
12 months post implantation
|
|
Hemocompatibility score
Délai: 12 months post implantation
|
To determine the aggregate net burden of HRAE in each patient, a tiered hierarchal score (hemocompatibility score [HCS]) that weights each event by its escalating clinical relevance was calculated for each patient as previously described.
(Mehra MR.
The burden of haemocompatibility with left ventricular assist systems: a complex weave.
Eur Heart J 2017.
doi: https:// doi.org/10.1093/eurheartj/ehx036.)
In brief, mild events contributed a single point to the HCS, whereas serious events contributed a higher grade to the HCS.
The HCS was calculated for each patient by summing up all the points associated with each HRAE experienced by the patient for the duration of available follow-up.
The HCS served as the net burden of all HRAEs experienced by the patient for the duration of 12-month follow-up.
|
12 months post implantation
|
|
Change in NYHA functional class from baseline
Délai: 12 months post implantation
|
Change in NYHA functional class from baseline
|
12 months post implantation
|
|
Change in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score from baseline
Délai: 12 months post implantation
|
Change in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score from baseline
|
12 months post implantation
|
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from baseline
Délai: 12 months post implantation
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from baseline
|
12 months post implantation
|
|
Change in exercise capacity (6-minute walk test) from baseline
Délai: 12 months post implantation
|
Change in exercise capacity (6-minute walk test) from baseline
|
12 months post implantation
|
Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Termes MeSH pertinents supplémentaires
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies vasculaires
- Maladies cardiovasculaires
- Processus pathologiques
- Embolie et thrombose
- Conditions pathologiques, signes et symptômes
- Accident vasculaire cérébral
- Thrombose
- Hémorragie
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Pyrans
- Coumarines
- Benzopyrans
- 4-hydroxycoumarines
- Warfarine
Autres numéros d'identification d'étude
- 2026-3116
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
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