Ignite Creation Date:
2024-05-06 @ 1:34 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04059679
Status:
UNKNOWN
Last Update Posted:
2020-10-14
First Post:
2019-08-14
Brief Title:
Synergistic Influence of Rivaroxaban on Inflammation and Coagulation Biomarkers in Patients With CAD and PAD on Aspirin Therapy
Sponsor:
LifeBridge Health
Organization:
LifeBridge Health
Study Overview
Official Title:
Synergistic Influence of Rivaroxaban on Inflammation and Coagulation Biomarkers in Patients With CAD and PAD on Aspirin Therapy
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 25 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None