The effect of rivaroxaban in addition to aspirin on the immune system in coronary artery disease
- Conditions
- coronary artery diseaseTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2021-006189-19-NL
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
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
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
oHypersensitivity to rivaroxaban
oat 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)
oSevere hepatic disease: Child Pugh B or C [9]
oSevere kidney failure: estimated glomerular filtration rate<15 ml/min or requiring dialysis
osevere heart failure with known ejection fraction < 30% or New York Heart Association class III or IV symptoms [10]
oconcomitant 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary Objective:<br>To demonstrate elevation in immune responsiveness to stimulation of whole blood with LPS when switching SAPT to DPI.<br><br>;Secondary Objective: Secondary Objective(s):<br>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 Outcome Measures
Name Time Method Secondary end point(s): -Changes in white blood cell count and distribution at 4 and 12 weeks after switching SAPT to DPI<br>-Change in monocyte immune responsiveness to LPS stimulation at 4 and 12 weeks after switching SAPT to DPI<br>-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<br>-Changes in circulating cytokines at 4 and 12 weeks after switching SAPT to DPI<br>;Timepoint(s) of evaluation of this end point: 3 months after start rivaroxaban with aspirin combination treatment