NCT07644247

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for phase_4

Timeline
43mo left

Started Jun 2026

Longer than P75 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

June 25, 2026

Expected
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

2.5 years

First QC Date

April 21, 2026

Last Update Submit

June 8, 2026

Conditions

LVADLVAD (Left Ventricular Assist Device)LVAD-related GI BleedBleedingThrombosisStrokeHemocompatibility-related Adverse EventVentricular Assist DeviceAspirinAntiplatelet TherapyAntithrombotic TherapyLVAD (Left Ventricular Assist Device) Thrombosis

Keywords

Left ventricular assist deviceLVADStrokeBleedingThrombosisHemocompatibilityAspirinAntiplatelet

Outcome Measures

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.

    12 months post implantation

Secondary Outcomes (15)

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

    12 months post implantation

  • Incidence of non-surgical bleeding

    12 months post implantation

  • Overall survival rate

    12 months post implantation

  • Incidence of stroke

    12 months post implantation

  • Incidence of pump thrombosis

    12 months post implantation

  • +10 more secondary outcomes

Study Arms (2)

Placebo group

EXPERIMENTAL

vitamin K antagonist with placebo

Drug: Warfarin (INR 2-3) with placebo

Aspirin group

ACTIVE COMPARATOR

vitamin K antagonist with aspirin

Drug: Warfarin (INR 2-3) with aspirin

Interventions

Warfarin (INR 2-3) with aspirinDRUG

Warfarin (INR 2-3) with aspirin

Aspirin group
Warfarin (INR 2-3) with placeboDRUG

Warfarin (INR 2-3) with placebo

Placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ThrombosisHemorrhageStroke

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Kai Chen, Dr

CONTACT

13269333241ck_2003@126.com

Zelin Yin

CONTACT

13321153733zelin_0823@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

June 12, 2026

Study Start (Estimated)

June 25, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share