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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Survival free from major hemocompatibility-related adverse events at 12 months post-implantation [Срок оценки: 12 months post implantation]

Вторичные конечные точки (12)

• Key Secondary Outcome: Incidence of major thromboembolic events at 12 months post-implantation [Срок оценки: 12 months post implantation]
• Incidence of non-surgical bleeding [Срок оценки: 12 months post implantation]
• Overall survival rate [Срок оценки: 12 months post implantation]
• Incidence of stroke [Срок оценки: 12 months post implantation]
• Incidence of pump thrombosis [Срок оценки: 12 months post implantation]
• Incidence of peripheral arterial embolism [Срок оценки: 12 months post implantation]
• Incidence of myocardial infarction [Срок оценки: 12 months post implantation]
• Incidence of aortic root thrombosis [Срок оценки: 12 months post implantation]
• Incidence of bleeding [Срок оценки: 12 months post implantation]
• Rehospitalization rate [Срок оценки: 12 months post implantation]
• Hemocompatibility score [Срок оценки: 12 months post implantation]
• Change in NYHA functional class from baseline [Срок оценки: 12 months post implantation]

Критерии участия

Критерии включения

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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.

Критерии исключения

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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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07644247 · 2026-3116

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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