Trained immunity by dual-pathway inhibition (low-dose rivaroxaban and acetylsalicylic acid) in coronary artery disease - DUALCAD

Radboudumc0 个研究点目标入组 20 人开始时间: 2021年12月16日最近更新: 2022年1月17日

适应症

试验速览

暂无简介。

•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

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