drugset / Trial / NCT03718429

Pharmacodynamic Effects of Low-dose Rivaroxaban With Antiplatelet Therapies

NCT03718429

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Recent studies indicate that anti-factor-Xa inhibition with low-dose rivaroxaban may have a role in the reduction of ischemic recurrences in patients with atherosclerotic disease manifestations. To date there is very little data, and not conducted in human subjects, on the interplay between anti-Xa blockade with low-dose rivaroxaban and antiplatelet therapies, and in particular how this affects profiles of platelet reactivity and thrombin generation. Given the potential role for the use of low-dose rivaroxaban for the prevention of ischemic recurrences in patients with atherothrombotic disease manifestations, including coronary artery disease (CAD) and peripheral arterial disease (PAD), the study team proposes a prospective pharmacodynamic (PD) investigation assessing the impact of low-dose rivaroxaban when used in combination with antiplatelet treatment regimens commonly used in clinical practice.

Timeline

Start
2019-01-14
Primary completion
2020-02-13
Completion
2020-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivaroxaban Other / unclassified 2.5 mg
Subject Rivaroxaban Other / unclassified 20 mg