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

Summary

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.

Conditions

• LVAD (Left Ventricular Assist Device) Thrombosis
• LVAD
• LVAD (Left Ventricular Assist Device)
• LVAD-related GI Bleed
• Bleeding
• Thrombosis
• Stroke
• Hemocompatibility-related Adverse Event
• Ventricular Assist Device
• Aspirin
• Antiplatelet Therapy
• Antithrombotic Therapy

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

Sponsors & Collaborators

• Beijing Anzhen Hospital

  collaborator OTHER

• Wuhan Asia Heart Hospital

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Jiangsu Provincial People's Hospital

  collaborator OTHER

• Second Hospital of Jilin University

  collaborator OTHER

• Nanjing First Hospital, Nanjing Medical University

  collaborator OTHER

• Zhejiang Provincial People's Hospital

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Fuwai Yunnan Cardiovascular Hospital

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Henan Provincial Chest Hospital

  collaborator OTHER

• Fujian Provincial Hospital

  collaborator OTHER

• People's Hospital of Xinjiang Uygur Autonomous Region

  collaborator OTHER

• Union hospital of Fujian Medical University

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• The 7th People's Hospital of Zhengzhou

  collaborator UNKNOWN

• Chinese Academy of Medical Sciences, Fuwai Hospital

  collaborator OTHER

• Xijing Hospital

  collaborator OTHER

• China National Center for Cardiovascular Diseases

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-25

Primary Completion

2029-01-01

Completion

2029-12-31