drugset / Trial / NCT03273322

Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure

NCT03273322 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

Evaluation of 2 doses of rivaroxaban (10 and 15 mg) compared to dual anti platelet therapy (aspirin+clopidogrel) after left atrial appendage closure. The patients will be assessed at 10 and 90 days: central laboratory hemostasis analysis and clinical events assessment.

Timeline

Start
2017-09-13
Primary completion
2018-11-20
Completion
2019-09-30

Outcome

Met primary endpoint

paper The primary end point was reduced with R10 (179 pmol/L [interquartile range (IQR), 129-273], P<0.0001) and R15 (163 pmol/L [IQR, 112-231], P<0.0001) as compared with DAPT (322 pmol/L [IQR, 218-528]). PMID 32674675 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 75 mg —
Comparator Clopidogrel Small molecule 75 mg —
Subject Rivaroxaban Other / unclassified 10 mg Oral
Subject Rivaroxaban Other / unclassified 15 mg Oral