Antiplatelet Therapy, Antithrombotic Therapy, Aspirin, Bleeding, Hemocompatibility-related Adverse Event, LVAD, LVAD (Left Ventricular Assist Device), LVAD (Left Ventricular Assist Device) Thrombosis, LVAD-related GI Bleed, Stroke, Thrombosis, Ventricular Assist Device
Conditions
Keywords
Left ventricular assist device, LVAD, Stroke, Bleeding, Thrombosis, Hemocompatibility, Aspirin, Antiplatelet
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.
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.
Interventions
DRUGWarfarin (INR 2-3) with placebo
Warfarin (INR 2-3) with placebo
DRUGWarfarin (INR 2-3) with aspirin
Warfarin (INR 2-3) with aspirin
Sponsors
China National Center for Cardiovascular Diseases
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
Wuhan Asia Heart Hospital Xinjiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival free from major hemocompatibility-related adverse events at 12 months post-implantation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Key Secondary Outcome: Incidence of major thromboembolic events at 12 months post-implantation | 12 months post implantation | Major thromboembolic events include ischemic stroke, suspected or confirmed pump thrombosis, peripheral arterial embolism, myocardial infarction, and aortic root thrombosis. |
| Incidence of non-surgical bleeding | 12 months post implantation | including non-surgical major bleeding and hemorrhagic stroke |
| Overall survival rate | 12 months post implantation | Overall survival rate |
| Incidence of stroke | 12 months post implantation | Including all stroke, hemorrhagic stroke, ischemic stroke, and disabling stroke |
| Incidence of pump thrombosis | 12 months post implantation | Including suspected pump thrombosis |
| Incidence of peripheral arterial embolism | 12 months post implantation | Incidence of peripheral arterial embolism |
| Incidence of myocardial infarction | 12 months post implantation | Incidence of myocardial infarction |
| Incidence of aortic root thrombosis | 12 months post implantation | Incidence of aortic root thrombosis |
| Incidence of bleeding | 12 months post implantation | Including major bleeding, gastrointestinal bleeding, and hemorrhagic stroke |
| Rehospitalization rate | 12 months post implantation | Rehospitalization rate |
| Hemocompatibility score | 12 months post implantation | 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. |
| Change in NYHA functional class from baseline | 12 months post implantation | Change in NYHA functional class from baseline |
| Change in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score from baseline | 12 months post implantation | Change in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score from baseline |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from baseline | 12 months post implantation | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from baseline |
| Change in exercise capacity (6-minute walk test) from baseline | 12 months post implantation | Change in exercise capacity (6-minute walk test) from baseline |
Contacts
CONTACTKai Chen, Dr
CONTACTZelin Yin
Outcome results
None listed