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Not yet recruiting NCT07644247

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

Phase IV Interventional LVAD (Left Ventricular Assist Device) Thrombosis LVAD LVAD (Left Ventricular Assist Device) LVAD-related GI Bleed

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Warfarin (INR 2-3) with placebo, Warfarin (INR 2-3) with aspirin.
Who it may be relevant to
Registry conditions: LVAD (Left Ventricular Assist Device) Thrombosis, LVAD, LVAD (Left Ventricular Assist Device), LVAD-related GI Bleed. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Detailed description

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.

Interventions

  • Drug Warfarin (INR 2-3) with placebo
    Warfarin (INR 2-3) with placebo
  • Drug Warfarin (INR 2-3) with aspirin
    Warfarin (INR 2-3) with aspirin

Primary outcome measures

  • Survival free from major hemocompatibility-related adverse events at 12 months post-implantation [Time frame: 12 months post implantation]
Secondary outcome measures (12)
  • Key Secondary Outcome: Incidence of major thromboembolic events at 12 months post-implantation [Time frame: 12 months post implantation]
  • Incidence of non-surgical bleeding [Time frame: 12 months post implantation]
  • Overall survival rate [Time frame: 12 months post implantation]
  • Incidence of stroke [Time frame: 12 months post implantation]
  • Incidence of pump thrombosis [Time frame: 12 months post implantation]
  • Incidence of peripheral arterial embolism [Time frame: 12 months post implantation]
  • Incidence of myocardial infarction [Time frame: 12 months post implantation]
  • Incidence of aortic root thrombosis [Time frame: 12 months post implantation]
  • Incidence of bleeding [Time frame: 12 months post implantation]
  • Rehospitalization rate [Time frame: 12 months post implantation]
  • Hemocompatibility score [Time frame: 12 months post implantation]
  • Change in NYHA functional class from baseline [Time frame: 12 months post implantation]

Eligibility criteria

Inclusion criteria

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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

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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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07644247 · 2026-3116

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗