Texas Cardiac Arrhythmia Research Foundation
This randomized study was designed to compare two antithrombotic regimens (long-term half-dose apixaban vs long-term aspirin after 45-days of full-dose apixaban) after successful Watchman implantation.
STUDY RATIONALE The primary hypothesis is that long-term half-dose apixaban would be superior to long-term aspirin for the primary endpoint. Primary analysis will be performed on an intention-to-treat (ITT) basis. A post-hoc secondary analysis will also be performed. STUDY OBJECTIVES Composite Primary Endpoint The primary endpoint will be a composite of device-related thrombosis (DRT), thromboembolic events \[stroke/transient ischemic attacks (TIA)\] and major bleeding events 4\. STUDY DESIGN Study Overview Patients will be randomly assigned to long-term half-dose apixaban or long-term aspir…
Inclusion Criteria: * • Men and women ≥18 years of age; * Patients who underwent a clinically successful LAA closure procedure with a Watchman device (device implanted without procedural or bleeding complication) within a day or are scheduled to undergo the LAAO procedure * Paroxysmal, persistent, or permanent AF patients irrespective of prior antithrombotic treatment are eligible for randomization, * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Two or more clinical characteristics at baseli…
Patients randomized to long-term half-dose apixaban (Group hdNOAC) will receive half-dose (2.5mg BID) apixaban monotherapy throughout the study period
In the low-dose ASA group, patients will receive full-dose of apixaban for 45 days followed by the low-dose aspirin
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