A Phase 4 interventional study of Rivaroxaban, dabigatran, apixaban, or edoxaban and Clopidogrel -75 mg/day in Left Atrial Appendage Closure, Thrombosis and Stroke, sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec · Phase 4, Interventional, and Prevention
The objective of the study is to compare short-term (8 weeks) anticoagulation therapy (DOAC) vs. antiplatelet therapy for the prevention of device thrombosis following transcatheter LAAC.
Transcatheter left atrial appendage closure (LAAC) has emerged as an alternative to anticoagulation for preventing thromboembolic events in patients with atrial fibrillation. Whereas most complications associated with LAAC have decreased over time, the occurrence of device thrombosis remains a concern, with an incidence of 1 to 17%. Antithrombotic therapy for preventing device thrombosis following LAAC has evolved empirically, with antiplatelet therapy being the most commonly prescribed treatment. However, the rates of device thrombosis post-LAAC remain relatively high and have not decreased over time despite of increasing operator/center experience and the arrival of newer generation devices. This is of particular concern if we consider that LAAC is a preventive treatment. Experimental and mechanistic studies have suggested enhanced thrombin generation (and not platelet activation) within the days-weeks following the procedure as the most important mechanism involved in device thrombosis and appropriate short-term anticoagulation therapy with DOAC should translate into a significant reduction in the rate of device thrombosis post-LAAC.
Therefore, the objective of the study is to compare short-term (60 days) anticoagulation therapy (DOAC) vs. antiplatelet therapy for the prevention of device thrombosis following transcatheter LAAC.
It is estimated that 350 patients will take part in the study.
Update: A blinded interim analysis was performed with the analysis of clinical and TEE (central echo core lab) data from the initial 155 patients included in the study. Based on the results of the interim analysis, and considering the total number of events and the high rate (20%) of patients with either early cessation of the allocated treatment (before the 60-day TEE examination) or missing TEE at 60 days, it was decided to increase the sample size by 160 patients up to a total of 510 patients. This would ensure to include at least 350 patients with a TEE examination performed while receiving the allocated antithrombotic treatment.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's planned enrollment of 510 is above the median of 106 across 849 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Direct oral anticoagulants (rivaroxaban, dabigatran, apixaban, or edoxaban; with dosage according to guideline recommendations) for 60 days.
Drug: Rivaroxaban, dabigatran, apixaban, or edoxaban
Dual antiplatelet therapy with clopidogrel -75 mg/day- and low dose aspirin -80 to 125 mg/day for 60 days.
Drug: Clopidogrel -75 mg/day · Drug: Low dose aspirin -80 to 125 mg/day-
Duration of treatment: 60 days
Duration of treatment: 60 days
Duration of treatment: 60 days
Device thrombosis (efficacy outcome)
Evaluated by TEE
Time frame: 60 days after LAAC
Combined outcome of all-cause mortality, bleeding, stroke, or Device thrombosis (Safety outcome)
Clinically evaluated and diagnosed by the center investigators and determining a treatment change.
Time frame: 60 days after LAAC
Device thrombosis
Evaluated by TEE or computed tomography
Time frame: 12 months after LAAC
Ischemic events
Stroke, TIA
Time frame: 60 days, 12-month, 2-year, 3-year, 4-year and 5-year follow-up
Bleeding events
Time frame: 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up
Major or Life-threatening bleeding events
Time frame: 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up
Mortality
All cause mortality
Time frame: 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up
Plan to share: Undecided
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec