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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
EC aspirin (81mg qd) plus rivaroxaban (2.5 mg bid)
EC aspirin 81 mg qd
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
RECRUITINGRelative Difference in maximal ADP-induced Platelet Aggregation
Relative difference in maximal ADP-induced platelet aggregation between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks.
Time frame: 12 weeks
Relative differences in TF-thrombin-induced platelet aggregation
Relative differences in TF-thrombin-induced platelet aggregation between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks.
Time frame: 12 weeks
Relative differences in alpha- thrombin-induced platelet aggregation
Relative differences in alpha- thrombin-induced platelet aggregation between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks.
Time frame: 12 weeks
Relative differences in inflammation biomarkers
Relative differences in IL-6, hsCRP, platelet bound p-selectin, VCAM, fibrinogen, oxLDL, oxLDL/atherox, TAT complexes, prothrombin F1+2, D-dimer and FpA (soluble markers) between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks
Time frame: 12 weeks
Relative differences in platelet-fibrin clot characteristics
Relative differences in platelet-fibrin clot characteristics between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks
Time frame: 12 weeks
Relative differences in shear-induced platelet aggregation
Relative differences in shear-induced platelet aggregation between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks
Time frame: 12 weeks
Relative differences in lag time
Relative differences in lag time between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks
Time frame: 12 weeks
Relative differences in peak thrombin production
Relative differences in peak thrombin production between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks
Time frame: 12 weeks
Relative differences in mean velocity rate index
Relative differences in mean velocity rate index between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks
Time frame: 12 weeks
Relative differences in endogenous thrombin potential
Relative differences in endogenous thrombin potential between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks
Time frame: 12 weeks
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