Synergistic Influence of Rivaroxaban on Inflammation and Coagulation Biomarkers in Patients With CAD and PAD on Aspirin Therapy
Status unconfirmed · Phase 4
Conditions studied: Coronary Artery Disease, Peripheral Artery Disease
In brief
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.
Key facts
- Study ID
- NCT04059679
- Run by
- LifeBridge Health
- People needed
- 30
- Starts
- 2020-01-30
- Expected to finish
- 2021-08-01
- Last updated by the study team
- 2020-10-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Sinai Hospital of Baltimore — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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