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| Name | Class |
|---|---|
| Beijing Anzhen Hospital | OTHER |
| Wuhan Asia Heart Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Jiangsu Provincial People's Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Experimental | vitamin K antagonist with placebo |
|
| Aspirin group | Active Comparator | vitamin K antagonist with aspirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin (INR 2-3) with placebo | Drug | Warfarin (INR 2-3) with placebo |
| |
| 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 |
| 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 |
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Inclusion Criteria:
-
Study participants must meet all the following criteria:
Exclusion Criteria:
-
Study participants meet any of the following criteria will be excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kai Chen, Dr | Contact | 13269333241 | ck_2003@126.com | |
| Zelin Yin | Contact | 13321153733 | zelin_0823@163.com |
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| OTHER |
| Second Hospital of Jilin University | OTHER |
| Nanjing First Hospital, Nanjing Medical University | OTHER |
| Zhejiang Provincial People's Hospital | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| Sichuan Provincial People's Hospital | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| Zhejiang University | OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| Fuwai Yunnan Cardiovascular Hospital | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| Henan Provincial Chest Hospital | OTHER |
| Fujian Provincial Hospital | OTHER |
| People's Hospital of Xinjiang Uygur Autonomous Region | OTHER |
| Union hospital of Fujian Medical University | OTHER |
| Ruijin Hospital | OTHER |
| The 7th People's Hospital of Zhengzhou | UNKNOWN |
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Xijing Hospital | OTHER |
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| Warfarin (INR 2-3) with aspirin |
| Drug |
Warfarin (INR 2-3) with aspirin |
|
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 |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D006470 | Hemorrhage |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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