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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Thrombosis; Bleeding; Aspirin; Antithrombotic Therapy; LVAD-related GI Bleed; Antiplatelet Therapy; LVAD; Ventricular Assist Device; LVAD (Left Ventricular Assist Device) Thrombosis; LVAD (Left Ventricular Assist Device); Hemocompatibility-related Adverse Event
• Intervention / Treatment: Drug: Warfarin (INR 2-3) with placebo; Drug: Warfarin (INR 2-3) with aspirin

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 Type: Interventional
• Enrollment (Estimated): 370
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kai Chen, Dr; Phone Number: 13269333241; Email: ck_2003@126.com
• Study Contact Backup: Name: Zelin Yin; Phone Number: 13321153733; Email: zelin_0823@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 informed consent form, and willing to comply with the study procedures and follow-up requirements.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo group; vitamin K antagonist with placebo	Drug: Warfarin (INR 2-3) with placebo; Warfarin (INR 2-3) with placebo
Active Comparator: Aspirin group; vitamin K antagonist with aspirin	Drug: Warfarin (INR 2-3) with aspirin; Warfarin (INR 2-3) with aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months post implantation
Incidence of non-surgical bleeding	including non-surgical major bleeding and hemorrhagic stroke	12 months post implantation
Overall survival rate	Overall survival rate	12 months post implantation
Incidence of stroke	Including all stroke, hemorrhagic stroke, ischemic stroke, and disabling stroke	12 months post implantation
Incidence of pump thrombosis	Including suspected pump thrombosis	12 months post implantation
Incidence of peripheral arterial embolism	Incidence of peripheral arterial embolism	12 months post implantation
Incidence of myocardial infarction	Incidence of myocardial infarction	12 months post implantation
Incidence of aortic root thrombosis	Incidence of aortic root thrombosis	12 months post implantation
Incidence of bleeding	Including major bleeding, gastrointestinal bleeding, and hemorrhagic stroke	12 months post implantation
Rehospitalization rate	Rehospitalization rate	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.	12 months post implantation
Change in NYHA functional class from baseline	Change in NYHA functional class from baseline	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	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	12 months post implantation
Change in exercise capacity (6-minute walk test) from baseline	Change in exercise capacity (6-minute walk test) from baseline	12 months post implantation

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: Xijing Hospital; Shanghai Zhongshan Hospital; First Affiliated Hospital Xi'an Jiaotong University; Ruijin Hospital; Nanjing First Hospital, Nanjing Medical University; Guangdong Provincial People's Hospital; Beijing Anzhen Hospital; People's Hospital of Xinjiang Uygur Autonomous Region; Zhejiang University; Sir Run Run Shaw Hospital; Wuhan Asia Heart Hospital; Chinese Academy of Medical Sciences, Fuwai Hospital; Zhejiang Provincial People's Hospital; First Affiliated Hospital of Xinjiang Medical University; Sichuan Provincial People's Hospital; Second Hospital of Jilin University; Fujian Provincial Hospital; Jiangsu Provincial People's Hospital; Union hospital of Fujian Medical University; Fuwai Yunnan Cardiovascular Hospital; Henan Provincial Chest Hospital; The 7th People's Hospital of Zhengzhou; Wuhan Asia Heart Hospital Xinjiang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 25, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Aspirin; Stroke; Thrombosis; Bleeding; Antiplatelet; LVAD; Left ventricular assist device; Hemocompatibility
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Embolism and Thrombosis; Pathological Conditions, Signs and Symptoms; Stroke; Thrombosis; Hemorrhage; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrans; Coumarins; Benzopyrans; 4-Hydroxycoumarins; Warfarin
• Other Study ID Numbers: 2026-3116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No