Trained immunity by dual-pathway inhibition (low-dose rivaroxaban and acetylsalicylic acid) in coronary artery disease
- Conditions
- atherosclerotic heart diseasecoronary artery disease10003216
- Registration Number
- NL-OMON50625
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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,
- at least16 years old
- Written informed consent
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,
dual-pathway inhibition, 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
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is a change in whole blood immune responsiveness to LPS<br /><br>stimulation when switching from ASA to DPI. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are changes in white blood cell count and distribution,<br /><br>change in monocyte immune responsiveness to LPS stimulation, change in<br /><br>enrichment of epigenetic marks on genes associated with inflammation in<br /><br>monocytes, and changes in circulating cytokines when switching from ASA to DPI.</p><br>