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Not yet recruitingNCT07644247STARUpdated Jun 12, 2026

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

A Phase 4 interventional study of Warfarin (INR 2-3) with placebo and Warfarin (INR 2-3) with aspirin in LVAD (Left Ventricular Assist Device) Thrombosis, LVAD and LVAD (Left Ventricular Assist Device), sponsored by China National Center for Cardiovascular Diseases. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by China National Center for Cardiovascular Diseases · Phase 4, Interventional, and Treatment

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Phase
Phase 4
Study type
Interventional
Enrollment
370
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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

Keywords

  • Left ventricular assist device
  • LVAD
  • Stroke
  • Bleeding
  • Thrombosis
  • Hemocompatibility
  • Aspirin
  • Antiplatelet
03

In context

Thrombosis

955 studies on the registry are indexed under Thrombosis; 171 are open to participants now.

This study's planned enrollment of 370 is above the median of 83 across 530 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 270 studies on the registry; 142 are open to participants now.

Browse China National Center for Cardiovascular Diseases studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-

Study participants must meet all the following criteria:

  1. Age ≥18 years old;
  2. Implanted with the CH-VAD pump for advanced heart failure, and the CH-VAD pump is the first implanted left ventricular assist device;
  3. Able to understand the study purpose, voluntarily participate and sign the form, and willing to comply with the study procedures and follow-up requirements.

Exclusion criteria

Exclusion Criteria:

-

Study participants meet any of the following criteria will be excluded:

  1. Requirement for additional temporary or permanent mechanical circulatory support after LVAD implantation;
  2. 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;
  3. Occurrence of primary endpoint events prior to randomization (within 2-7 days after implantation);
  4. Inability to take oral medications post-implant through 7 days;
  5. Known allergy to aspirin;
  6. Participation in another clinical investigation that may affect study outcome;
  7. 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
370 participants (estimated)

Study arms

  • Experimental
    Placebo group

    vitamin K antagonist with placebo

    Drug: Warfarin (INR 2-3) with placebo

  • Active comparator
    Aspirin group

    vitamin K antagonist with aspirin

    Drug: Warfarin (INR 2-3) with aspirin

Interventions

  • DrugWarfarin (INR 2-3) with placebo

    Warfarin (INR 2-3) with placebo

  • DrugWarfarin (INR 2-3) with aspirin

    Drug pages: Warfarin · Aspirin

    Warfarin (INR 2-3) with aspirin

06

What researchers measure

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

  5. Incidence of pump thrombosis

    Including suspected pump thrombosis

    Time frame: 12 months post implantation

  6. Incidence of peripheral arterial embolism

    Incidence of peripheral arterial embolism

    Time frame: 12 months post implantation

  7. Incidence of myocardial infarction

    Incidence of myocardial infarction

    Time frame: 12 months post implantation

  8. Incidence of aortic root thrombosis

    Incidence of aortic root thrombosis

    Time frame: 12 months post implantation

  9. Incidence of bleeding

    Including major bleeding, gastrointestinal bleeding, and hemorrhagic stroke

    Time frame: 12 months post implantation

  10. Rehospitalization rate

    Rehospitalization rate

    Time frame: 12 months post implantation

  11. Hemocompatibility score

    To determine the aggregate net burden of HRAE in each patient, a tiered hierarchal score (hemocompatibility score \[HCS\]) that weights each event by its escalating clinical relevance was calculated for each patient as previously described. (Mehra MR. The burden of haemocompatibility with left ventricular assist systems: a complex weave. Eur Heart J 2017. doi: https:// doi.org/10.1093/eurheartj/ehx036.) In brief, mild events contributed a single point to the HCS, whereas serious events contributed a higher grade to the HCS. The HCS was calculated for each patient by summing up all the points associated with each HRAE experienced by the patient for the duration of available follow-up. The HCS served as the net burden of all HRAEs experienced by the patient for the duration of 12-month follow-up.

    Time frame: 12 months post implantation

  12. Change in NYHA functional class from baseline

    Change in NYHA functional class from baseline

    Time frame: 12 months post implantation

  13. Change in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score from baseline

    Change in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score from baseline

    Time frame: 12 months post implantation

  14. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from baseline

    Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from baseline

    Time frame: 12 months post implantation

  15. Change in exercise capacity (6-minute walk test) from baseline

    Change in exercise capacity (6-minute walk test) from baseline

    Time frame: 12 months post implantation

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Jan 2029, 30 months later.

Of 34 phase 4 interventional studies under Thrombosis, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 63. This study's planned 30 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2026
First posted
Jun 12, 2026
StartEst.
Jun 25, 2026
Primary completionEst.
Jan 1, 2029
CompletionEst.
Dec 31, 2029
Last update
Jun 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07644247
Lead sponsor
China National Center for Cardiovascular Diseases
Collaborators
Beijing Anzhen Hospital, Wuhan Asia Heart Hospital, Shanghai Zhongshan Hospital, Jiangsu Provincial People's Hospital, Second Hospital of Jilin University, Nanjing First Hospital, Nanjing Medical University, Zhejiang Provincial People's Hospital, Sir Run Run Shaw Hospital, Sichuan Provincial People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, Zhejiang University, First Affiliated Hospital of Xinjiang Medical University, Fuwai Yunnan Cardiovascular Hospital, Guangdong Provincial People's Hospital, Henan Provincial Chest Hospital, Fujian Provincial Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, Union hospital of Fujian Medical University, Ruijin Hospital, The 7th People's Hospital of Zhengzhou, Chinese Academy of Medical Sciences, Fuwai Hospital, Xijing Hospital
Responsible party
Sponsor
First posted
Jun 12, 2026
Start date
Jun 25, 2026 (estimated)
Primary completion
Jan 1, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jun 12, 2026

Study contacts

Kai Chen, Dr
Contact
ck_2003@126.com
13269333241
Zelin Yin
Contact
zelin_0823@163.com
13321153733

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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