- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: Kai Chen, Dr
- Telefonnummer: 13269333241
- E-post: ck_2003@126.com
Studer Kontakt Backup
- Navn: Zelin Yin
- Telefonnummer: 13321153733
- E-post: zelin_0823@163.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Placebo group
vitamin K antagonist with placebo
|
Warfarin (INR 2-3) with placebo
|
|
Aktiv komparator: Aspirin group
vitamin K antagonist with aspirin
|
Warfarin (INR 2-3) with aspirin
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Survival free from major hemocompatibility-related adverse events at 12 months post-implantation
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Key Secondary Outcome: Incidence of major thromboembolic events at 12 months post-implantation
Tidsramme: 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
Tidsramme: 12 months post implantation
|
including non-surgical major bleeding and hemorrhagic stroke
|
12 months post implantation
|
|
Overall survival rate
Tidsramme: 12 months post implantation
|
Overall survival rate
|
12 months post implantation
|
|
Incidence of stroke
Tidsramme: 12 months post implantation
|
Including all stroke, hemorrhagic stroke, ischemic stroke, and disabling stroke
|
12 months post implantation
|
|
Incidence of pump thrombosis
Tidsramme: 12 months post implantation
|
Including suspected pump thrombosis
|
12 months post implantation
|
|
Incidence of peripheral arterial embolism
Tidsramme: 12 months post implantation
|
Incidence of peripheral arterial embolism
|
12 months post implantation
|
|
Incidence of myocardial infarction
Tidsramme: 12 months post implantation
|
Incidence of myocardial infarction
|
12 months post implantation
|
|
Incidence of aortic root thrombosis
Tidsramme: 12 months post implantation
|
Incidence of aortic root thrombosis
|
12 months post implantation
|
|
Incidence of bleeding
Tidsramme: 12 months post implantation
|
Including major bleeding, gastrointestinal bleeding, and hemorrhagic stroke
|
12 months post implantation
|
|
Rehospitalization rate
Tidsramme: 12 months post implantation
|
Rehospitalization rate
|
12 months post implantation
|
|
Hemocompatibility score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 12 months post implantation
|
Change in exercise capacity (6-minute walk test) from baseline
|
12 months post implantation
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Patologiske prosesser
- Embolisme og trombose
- Patologiske tilstander, tegn og symptomer
- Slag
- Trombose
- Blødning
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Pyraner
- Kumariner
- Benzopyraner
- 4-hydroxycoumarins
- Warfarin
Andre studie-ID-numre
- 2026-3116
Plan for individuelle deltakerdata (IPD)
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