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| Name | Class |
|---|---|
| Second Affiliated Hospital of Nantong University | OTHER |
| Jiangsu Taizhou People's Hospital | OTHER |
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The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of silent cerebral embolism.
BACKGROUND Left atrial appendage intervention is increasingly recognized as an alternative strategy for thromboembolism prophylaxis in AF. Theoretically, a complete occlusion of left atrial appendage may eliminate the possibility of embolism from the appendage. However, residual risk exists due to blood stasis and endothelial dysfunction in the atrial fibrillation state. This may raise an issue that whether we should and how to give the patients after appendage occlusion long-term antithrombotic therapy.
Meanwhile, patients with AF have a high incidence of silent cerebral embolism (SCE), which has similar impact with clinical stroke on cognition function. We hypothesized that the SCE caused by micro embolism may act as part of the residual risk after appendage occlusion, thus, an optimal antithrombotic treatment to decrease the incidence of SCE remains unclear.
AIM OF THIS STUDY The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of SCE. The primary endpoint is incidence of SCE detected by MRI. The secondary endpoints are more than two new SCE detected by MRI, cognition function and composite endpoint of all-cause mortality, clinical thromboembolic events and major bleeding events.
DESIGN This is a randomized, prospective, multicenter design. We aim to include 150 patients 45 days after successful LAAC with WATCHMAN device. Patients are randomized in a 1:1 fashion into two arms: Standard Antiplatelet Therapy and Half-Dose NOAC. Follow-up duration of this study is 12 months. The 1-year routine follow-up strategy included DW-MRI scans performed approximately 90 days, 180 days, and 365 days post-procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Antiplatelet Therapy | Active Comparator | DAPT (aspirin 100 mg and clopidogrel 75 mg) from 45 days to 6 month-follow-up, then aspirin alone |
|
| Half-Dose NOAC | Experimental | Long-term half-dose NOAC (rivaroxaban 10 mg after 45 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspirin and clopidogrel | Drug | DAPT (until 6 months) + ASA |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of silent cerebral embolism (SCE) detected by MRI | New SCE at any MRI during the follow-up | 45 days to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| More than two new SCE detected by MRI | More than two new SCE at any MRI during the follow-up, describing the number, location and the size. | 45 days to 12 months |
| Cognition function detected by MMSE test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kexin Wang, MD | Contact | 18018223427 | 840507356@qq.com | |
| Weizhu Ju, MD | Contact | 15358162522 | juweizhu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| Rivaroxaban |
| Drug |
half-dose NOAC |
|
Cognition score detected by MMSE test
| 45 days to 12 months |
| MoCA test | Cognition score detected by MoCA test | 45 days to 12 months |
| Composite endpoint of of all-cause mortality, clinical thromboembolic events and major bleeding events | Clinical thromboembolic including Ischemic stroke, Peripheral thromboembolic event, et al. Major bleeding including intracrania bleeding, gastrointestina bleeding et al. | 45 days to 12 months |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009025 | Morpholines |
| D010078 | Oxazines |
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