LVAD (Left Ventricular Assist Device) ThrombosisPhase 4STARNCT07644247
STudy of Aspirin Removal in Patients Supported by the Fully Magnetically Levitated CH-VAD Pump
A Phase 4 study testing Warfarin (INR 2-3) with aspirin in people with LVAD (Left Ventricular Assist Device) Thrombosis and LVAD, run by China National Center for Cardiovascular Diseases.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LVAD (Left Ventricular Assist Device) Thrombosis, LVAD, LVAD (Left Ventricular Assist Device)
- What is being tested?
- Warfarin (INR 2-3) with aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2026to 31 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- 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.
Who cannot join
- -
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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)
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.
- Conditions
- LVAD (Left Ventricular Assist Device) Thrombosis, LVAD, LVAD (Left Ventricular Assist Device), LVAD-related GI Bleed, Bleeding, Thrombosis
- Being tested
- Warfarin (INR 2-3) with placebo, Warfarin (INR 2-3) with aspirin
- Keywords
- Left ventricular assist device, LVAD, Stroke, Bleeding, Thrombosis, Hemocompatibility, Aspirin, Antiplatelet
- Medical subject headings
- Thrombosis, Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warfarin (INR 2-3) with placeboDrug
Warfarin (INR 2-3) with placebo
Warfarin (INR 2-3) with aspirinDrug
Warfarin (INR 2-3) with aspirin
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Experimental | vitamin K antagonist with placebo Receives: Drug: Warfarin (INR 2-3) with placebo |
| Aspirin group | Active comparator | vitamin K antagonist with aspirin Receives: Drug: Warfarin (INR 2-3) with aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post implantation
Secondary outcomes (15)
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.
Measured: 12 months post implantation
Incidence of non-surgical bleeding
including non-surgical major bleeding and hemorrhagic stroke
Measured: 12 months post implantation
Overall survival rate
Overall survival rate
Measured: 12 months post implantation
Incidence of stroke
Including all stroke, hemorrhagic stroke, ischemic stroke, and disabling stroke
Measured: 12 months post implantation
Incidence of pump thrombosis
Including suspected pump thrombosis
Measured: 12 months post implantation
Incidence of peripheral arterial embolism
Incidence of peripheral arterial embolism
Measured: 12 months post implantation
Incidence of myocardial infarction
Incidence of myocardial infarction
Measured: 12 months post implantation
Incidence of aortic root thrombosis
Incidence of aortic root thrombosis
Measured: 12 months post implantation
Incidence of bleeding
Including major bleeding, gastrointestinal bleeding, and hemorrhagic stroke
Measured: 12 months post implantation
Rehospitalization rate
Rehospitalization rate
Measured: 12 months post implantation
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.
Measured: 12 months post implantation
Change in NYHA functional class from baseline
Change in NYHA functional class from baseline
Measured: 12 months post implantation
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
Measured: 12 months post implantation
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from baseline
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from baseline
Measured: 12 months post implantation
Change in exercise capacity (6-minute walk test) from baseline
Change in exercise capacity (6-minute walk test) from baseline
Measured: 12 months post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start25 Jun 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LVAD (Left Ventricular Assist Device) ThrombosisStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- 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, First Affiliated Hospital of 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644247
- Sponsor's protocol ID
- 2026-3116
- Acronym
- STAR
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07644247
- Acronym / sponsor ID
- STAR / 2026-3116
- Conditions
- LVAD (Left Ventricular Assist Device) Thrombosis, LVAD, LVAD (Left Ventricular Assist Device), LVAD-related GI Bleed, Bleeding, Thrombosis
- Keywords
- Left ventricular assist device, LVAD, Stroke, Bleeding, Thrombosis, Hemocompatibility, Aspirin, Antiplatelet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- 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, First Affiliated Hospital of 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
- Study start
- 25 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Experimental | Drug: Warfarin (INR 2-3) with placebovitamin K antagonist with placebo |
| Aspirin group | Active comparator | Drug: Warfarin (INR 2-3) with aspirinvitamin K antagonist with aspirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -
- 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.
Key exclusion criteria (9 listed)
- -
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warfarin (INR 2-3) with placeboWarfarin (INR 2-3) with placebo | Drug | Placebo group |
| Warfarin (INR 2-3) with aspirinWarfarin (INR 2-3) with aspirin | Drug | Aspirin group |
Primary outcome
Survival free from major hemocompatibility-related adverse events at 12 months post-implantation
Time frame: 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.
15 secondary outcomes
Key Secondary Outcome: Incidence of major thromboembolic events at 12 months post-implantation
Time frame: 12 months post implantation
Incidence of non-surgical bleeding
Time frame: 12 months post implantation
Overall survival rate
Time frame: 12 months post implantation
Incidence of stroke
Time frame: 12 months post implantation
Incidence of pump thrombosis
Time frame: 12 months post implantation
Incidence of peripheral arterial embolism
Time frame: 12 months post implantation
Incidence of myocardial infarction
Time frame: 12 months post implantation
Incidence of aortic root thrombosis
Time frame: 12 months post implantation
Incidence of bleeding
Time frame: 12 months post implantation
Rehospitalization rate
Time frame: 12 months post implantation
Hemocompatibility score
Time frame: 12 months post implantation
Change in NYHA functional class from baseline
Time frame: 12 months post implantation
Change in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score from baseline
Time frame: 12 months post implantation
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from baseline
Time frame: 12 months post implantation
Change in exercise capacity (6-minute walk test) from baseline
Time frame: 12 months post implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Warfarin (INR 2-3) with aspirin in people with LVAD (Left Ventricular Assist Device) Thrombosis and LVAD, run by China National Center for Cardiovascular Diseases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Chen, Dr (13269333241, ck_2003@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival free from major hemocompatibility-related adverse events at 12 months post-implantation (time frame: 12 months post implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.