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STudy of Aspirin Removal in Patients Supported by the Fully Magnetically Levitated CH-VAD Pump (STAR)

8. juni 2026 opdateret af: China National Center for Cardiovascular Diseases

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)

This multi-center, prospective, randomized, double-blinded, placebo-controlled study aims to investigate whether withdrawal of aspirin from the antithrombotic regimen in patients supported with the CH-VAD pump is non-inferior to the standard antithrombotic regimen of vitamin K antagonist combined with aspirin in terms of safety and efficacy.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a multi-center, prospective, randomized, double-blind, placebo-controlled, non-inferiority clinical investigation designed to evaluate two different antithrombotic regimens in advanced heart failure patients treated with the CH-VAD pump. The clinical investigation will be conducted at up to 30 centers in China. Eligible study participants will be randomized between postoperative day 2 and day 7 in a 1:1 ratio to receive either vitamin K antagonist with aspirin (Aspirin group) or vitamin K antagonist with placebo (Placebo group). Scheduled visits and assessments will be conducted at 1, 3, 6, 9, and 12 months post-implantation.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

370

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

-

Study participants must meet all the following criteria:

  1. Age ≥18 years old;
  2. Implanted with the CH-VAD pump for advanced heart failure, and the CH-VAD pump is the first implanted left ventricular assist device;
  3. 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:

  1. Requirement for additional temporary or permanent mechanical circulatory support after LVAD implantation;
  2. 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;
  3. Occurrence of primary endpoint events prior to randomization (within 2-7 days after implantation);
  4. Inability to take oral medications post-implant through 7 days;
  5. Known allergy to aspirin;
  6. Participation in another clinical investigation that may affect study outcome;
  7. 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Placebo group
vitamin K antagonist with placebo
Medicin: Warfarin (INR 2-3) with placebo
Warfarin (INR 2-3) with placebo
Aktiv komparator: Aspirin group
vitamin K antagonist with aspirin
Medicin: Warfarin (INR 2-3) with aspirin
Warfarin (INR 2-3) with aspirin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

China National Center for Cardiovascular Diseases

Samarbejdspartnere

Xijing Hospital
Shanghai Zhongshan Hospital
First Affiliated Hospital Xi'an Jiaotong University
Ruijin Hospital
Nanjing First Hospital, Nanjing Medical University
Guangdong Provincial People's Hospital
Beijing Anzhen Hospital
People's Hospital of Xinjiang Uygur Autonomous Region
Zhejiang University
Sir Run Run Shaw Hospital
Wuhan Asia Heart Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
Zhejiang Provincial People's Hospital
First Affiliated Hospital of Xinjiang Medical University
Sichuan Provincial People's Hospital
Second Hospital of Jilin University
Fujian Provincial Hospital
Jiangsu Provincial People's Hospital
Union hospital of Fujian Medical University
Fuwai Yunnan Cardiovascular Hospital
Henan Provincial Chest Hospital
The 7th People's Hospital of Zhengzhou
Wuhan Asia Heart Hospital Xinjiang Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

25. juni 2026

Primær færdiggørelse (Anslået)

1. januar 2029

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

21. april 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-3116

Plan for individuelle deltagerdata (IPD)

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