Synergistic Influence of Rivaroxaban on Inflammation and Coagulation Biomarkers in Patients With CAD and PAD on Aspirin Therapy

Summary

This is a phase IV, prospective biomarker study that will be conducted at Sinai Hospital of Baltimore. After screening for patients who were treated with aspirin, thirty patients will be treated with 81 mg enteric coated (EC) aspirin for 7 days in the "lead-in" period and then will be randomly treated with EC aspirin (81mg qd) or EC aspirin (81mg qd) plus rivaroxaban (2.5 mg bid) for 12 weeks. Platelet aggregation, soluble markers of platelet activation and inflammation, thrombin generation kinetics and tissue factor (TF)-induced platelet-fibrin clot strength will be assessed at baseline (after 7 days of treatment with 81 mg EC aspirin), and 4 and 12 weeks after randomization of the study drug administration.

Timeline

Start

2020-01-30

Primary completion

2021-03

Completion

2021-08

Publications

• Tantry U, Cummings C, Mackrell P, Gonze M, Ulloa K, Bafford R, Rout A, Sukhi A, Gurbel P. Synergistic influence of rivaroxaban on inflammation and coagulation biomarkers in patients with coronary artery disease and peripheral artery disease on aspirin therapy. Future Cardiol. 2020 Mar;16(2):69-75. doi: 10.2217/fca-2019-0091. Epub 2020 Mar 4.

Drugs

Indications