Status:
UNKNOWN
Trained Immunity by Dual-pathway Inhibition in Coronary Artery Disease
Lead Sponsor:
Radboud University Medical Center
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
Coronary artery disease (CAD) is a manifestation of systemic atherosclerosis for which single antiplatelet therapy (SAPT) is indicated if patients are stable. Recently dual pathway inhibition (DPI) by...
Eligibility Criteria
Inclusion
- 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,
- high cardiovascular risk based on a SMART risk score \[9\] of at least 20% and/or the judgement of the cardiologist
- at least 1 year after myocardial infarction or multivessel CAD
- \>16 years old
- Written informed consent
Exclusion
- 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)
- Use of immunosuppressant and/or anti-inflammatory therapy, including glucocorticoids, cytostatics, antibodies, immunophilins, interferons, Tumor Necrosis Factor (TNF) binding proteins, mycophenolate and interleukin antagonists
- Contra-indication to rivaroxaban
- Hypersensitivity to rivaroxaban
- 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)
- Severe hepatic disease: Child Pugh B or C \[10\]
- Severe kidney failure: estimated glomerular filtration rate\<15 ml/min or requiring dialysis
- severe heart failure with known ejection fraction \< 30% or New York Heart Association class III or IV symptoms \[12\]
- concomitant treatment with medication with a strong pharmacokinetic interaction with rivaroxaban, leading to contra-indication according to the "regionale\_NOAC\_richtlijn" \[12\]
- Pregnant or breastfeeding women
- Unable to give informed consent
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05210725
Start Date
March 1 2022
End Date
July 1 2022
Last Update
April 20 2022
Active Locations (1)
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1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525GA