coronary artery disease
Conditions
Interventions
Sponsors
Radboudumc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Stable CAD - with an indication for single antiplatelet therapy according to international (ESC) guidelines, - >16 years old - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Use of more intensive antithrombotic treatment (dual antiplatelet therapy, DPI, direct oral anticoagulants, vitamin k antagonists) - Contra-indication to rivaroxaban o Hypersensitivity to rivaroxaban o at significant risk for major bleeding ? current gastrointestinal ulceration ? presence of malignant neoplasms, with the exception of non-melanoma skin cancer ? recent (<2 months) brain or spinal injury ? recent (<3 months) brain or spinal surgery ? recent (<3 months) intracranial, gastrointestinal or pulmonary hemorrhage ? presence of arteriovenous malformations, ? major intraspinal or intracerebral vascular abnormalities ? congenital or acquired bleeding disorders ? uncontrolled severe arterial hypertension (180 mmHg or more systolic, or 110 mmHg or more diastolic) o Severe hepatic disease: Child Pugh B or C [9] o Severe kidney failure: estimated glomerular filtration rate<15 ml/min or requiring dialysis o severe heart failure with known ejection fraction < 30% or New York Heart Association class III or IV symptoms [10] o concomitant treatment with medication with a strong pharmacokinetic interaction with rivaroxaban, leading to contra-indication according to the “regionale_NOAC_richtlijn” [11] - Pregnant or breastfeeding women - Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: To demonstrate elevation in immune responsiveness to stimulation of whole blood with LPS when switching SAPT to DPI. ;Secondary Objective: Secondary Objective(s): To explore changes in immune cell distribution in blood, as well as monocyte function and epigenetic landscape in the observed elevation in immune responsiveness to LPS stimulation when switching SAPT to DPI.;Primary end point(s): -Change in whole blood immune responsiveness to LPS stimulation at 4 and 12 weeks after switching SAPT to DPI;Timepoint(s) of evaluation of this end point: 3 months after start rivaroxaban with aspirin combination treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Changes in white blood cell count and distribution at 4 and 12 weeks after switching SAPT to DPI - Change in monocyte immune responsiveness to LPS stimulation at 4 and 12 weeks after switching SAPT to DPI - Change in enrichment of epigenetic marks on genes associated with inflammation in monocytes as measured by Chromatin Immuno-precipitation at 4 and 12 weeks after switching SAPT to DPI - Changes in circulating cytokines at 4 and 12 weeks after switching SAPT to DPI ;Timepoint(s) of evaluation of this end point: 3 months after start rivaroxaban with aspirin combination treatment | — |
Countries
Netherlands
Contacts
Public ContactVascular surgery
Radboudumc
Outcome results
None listed