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Comparison among three different antithrombotic strategies after percutaneous LAA occlusion with a Watchman FLX LAAC device.
Data on the optimal antithrombotic therapy (AT) after percutaneous left atrial appendage (LAA) occlusion are still scarce. The classical AT strategy after LAA occlusion includes 6-weeks of warfarin + aspirin followed by dual anti platelet therapy with clopidogrel (75 mg) and aspirin (81-325 mg) until 6 months of follow-up, then aspirin alone is continued indefinitely. Nonetheless, a significant number of patients continues to suffer from device-related thrombosis which carries a high risk of thromboembolic events. Other AT strategies have been tested in order to reduce the risk of thrombus-formation on device. Among them, replacement of clopidogrel with half-dose oral anticoagulation (OAC) in patients with genetic resistance to this drug has been recently reported to reduce the incidence of DRT. Additionally, reduced dose of novel OAC was demonstrated to lead to lower thrombin generation compared to DAPT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Antithrombotic Therapy | Active Comparator | OAC for 6 weeks followed by DAPT until 6 month-follow-up, then aspirin alone |
|
| Genetic-Tailored AntiThrombotic Strategy | Active Comparator | OAC for 6 weeks followed by DAPT (clopidogrel responders) or aspirin plus half-dose OAC (clopidogrel non-responders) until 6 month-follow-up, then aspirin alone |
|
| Half-Dose NOAC | Active Comparator | Half Dose of Novel OAC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASA plus Clopidogrel | Drug | OAC (6 weeks) + DAPT (until 6 months) + ASA |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Stroke, Systemic Embolism, and Device-related Thrombosis | 1 year | |
| Incidence of Major Bleeding Events | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Minor Bleeding Events | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Domenico G Della Rocca, MD | Contact | 7375296806 | domenicodellarocca@hotmail.it | |
| Andrea Natale, MD | Contact | 5127842651 | andrea.natale@stdavids.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. David's Medical Center | Recruiting | Austin | Texas | 78705 | United States |
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| Genetic-Tailored AntiThrombotic Strategy |
| Drug |
Half-Dose OAC or Clopidogrel in combination with ASA on the basis of CYP2C19 Genotype |
|
| Half-Dose of novel OAC | Drug | Half Dose of novel OAC post-device Implantation |
|
| 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 |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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