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- Klinische proef 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)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Geschat)
Fase
- Fase 4
Contacten en locaties
Studiecontact
- Naam: Kai Chen, Dr
- Telefoonnummer: 13269333241
- E-mail: ck_2003@126.com
Studie Contact Back-up
- Naam: Zelin Yin
- Telefoonnummer: 13321153733
- E-mail: zelin_0823@163.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Placebo group
vitamin K antagonist with placebo
|
Warfarin (INR 2-3) with placebo
|
|
Actieve vergelijker: Aspirin group
vitamin K antagonist with aspirin
|
Warfarin (INR 2-3) with aspirin
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Survival free from major hemocompatibility-related adverse events at 12 months post-implantation
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Key Secondary Outcome: Incidence of major thromboembolic events at 12 months post-implantation
Tijdsspanne: 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
Tijdsspanne: 12 months post implantation
|
including non-surgical major bleeding and hemorrhagic stroke
|
12 months post implantation
|
|
Overall survival rate
Tijdsspanne: 12 months post implantation
|
Overall survival rate
|
12 months post implantation
|
|
Incidence of stroke
Tijdsspanne: 12 months post implantation
|
Including all stroke, hemorrhagic stroke, ischemic stroke, and disabling stroke
|
12 months post implantation
|
|
Incidence of pump thrombosis
Tijdsspanne: 12 months post implantation
|
Including suspected pump thrombosis
|
12 months post implantation
|
|
Incidence of peripheral arterial embolism
Tijdsspanne: 12 months post implantation
|
Incidence of peripheral arterial embolism
|
12 months post implantation
|
|
Incidence of myocardial infarction
Tijdsspanne: 12 months post implantation
|
Incidence of myocardial infarction
|
12 months post implantation
|
|
Incidence of aortic root thrombosis
Tijdsspanne: 12 months post implantation
|
Incidence of aortic root thrombosis
|
12 months post implantation
|
|
Incidence of bleeding
Tijdsspanne: 12 months post implantation
|
Including major bleeding, gastrointestinal bleeding, and hemorrhagic stroke
|
12 months post implantation
|
|
Rehospitalization rate
Tijdsspanne: 12 months post implantation
|
Rehospitalization rate
|
12 months post implantation
|
|
Hemocompatibility score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 12 months post implantation
|
Change in exercise capacity (6-minute walk test) from baseline
|
12 months post implantation
|
Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Cerebrovasculaire aandoeningen
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Vaatziekten
- Hart-en vaatziekten
- Pathologische processen
- Embolie en trombose
- Pathologische aandoeningen, tekenen en symptomen
- Hartinfarct
- Trombose
- Bloeding
- Heterocyclische verbindingen, 1-ring
- Heterocyclische verbindingen
- Heterocyclische verbindingen, 2-ring
- Heterocyclische verbindingen, gefuseerd ring
- Pyrans
- Coumarins
- Benzopyrans
- 4-hydroxycoumarins
- Warfarine
Andere studie-ID-nummers
- 2026-3116
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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