NCT04059679

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: LifeBridge Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Peripheral Artery Disease

Interventions

Type	Name	Description
DRUG	Rivaroxaban 2.5 Mg Oral Tablet	EC aspirin (81mg qd) plus rivaroxaban (2.5 mg bid)
DRUG	Aspirin 81 mg	EC aspirin 81 mg qd

Timeline

• Start date: 2020-01-30
• Primary completion: 2021-03-01
• Completion: 2021-08-01
• First posted: 2019-08-16
• Last updated: 2020-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study