Health TrialsbyHealthPanel

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

ConditionsLVAD (Left Ventricular Assist Device) ThrombosisLVADLVAD (Left Ventricular Assist Device)LVAD-related GI BleedBleedingThrombosisStrokeHemocompatibility-related Adverse EventVentricular Assist DeviceAspirinAntiplatelet TherapyAntithrombotic Therapy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Warfarin (INR 2-3) with placebo

    Drug

    Warfarin (INR 2-3) with placebo

  • Warfarin (INR 2-3) with aspirin

    Drug

    Warfarin (INR 2-3) with aspirin

Treatment groups

370 Participants
are divided into 2 treatment groups
Group A: Placebo groupExperimental treatment 1 intervention
Group B: Aspirin groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Survival free from major hemocompatibility-related adverse events at 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.

Time frame
12 months post implantation

Secondary outcomes

1

Key Secondary Outcome: Incidence of major thromboembolic events at 12 months post-implantation

Major thromboembolic events include ischemic stroke, suspected or confirmed pump thrombosis, peripheral arterial embolism, myocardial infarction, and aortic root thrombosis.

Time frame
12 months post implantation
2

Incidence of non-surgical bleeding

including non-surgical major bleeding and hemorrhagic stroke

Time frame
12 months post implantation
3

Overall survival rate

Overall survival rate

Time frame
12 months post implantation
4

Incidence of stroke

Including all stroke, hemorrhagic stroke, ischemic stroke, and disabling stroke

Time frame
12 months post implantation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Center for Cardiovascular Diseases

Lead sponsor

Beijing Anzhen Hospital

Collaborator

Wuhan Asia Heart Hospital

Collaborator

Shanghai Zhongshan Hospital

Collaborator

Jiangsu Provincial People's Hospital

Collaborator

Second Hospital of Jilin University

Collaborator

Nanjing First Hospital, Nanjing Medical University

Collaborator

Zhejiang Provincial People's Hospital

Collaborator

Sir Run Run Shaw Hospital

Collaborator

Sichuan Provincial People's Hospital

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator

Zhejiang University

Collaborator

First Affiliated Hospital of Xinjiang Medical University

Collaborator

Fuwai Yunnan Cardiovascular Hospital

Collaborator

Guangdong Provincial People's Hospital

Collaborator

Henan Provincial Chest Hospital

Collaborator

Fujian Provincial Hospital

Collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

Collaborator

Union hospital of Fujian Medical University

Collaborator

Ruijin Hospital

Collaborator

The 7th People's Hospital of Zhengzhou

Collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborator

Xijing Hospital

Collaborator

Source ClinicalTrials.gov

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