Stabilization of vulnerable atherosclerotic carotid plaques by Rivaroxaban as evaluated by 3D contrast enhanced ultrasound (CEUS)
EU CTIS ID: 2024-518539-13-00
What this study is testing
To observe the effect of rivaroxaban on atherosclerotic plaque morphology in carotid artery over time, registered by 3D contrast enhanced ultrasound.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Oral and written informed consent. - Adults > 18 years of age. - Acetylsalic acid (aspirin) therapy > 6 months. - Statin therapy > 6 months. - Asymptomatic carotid stenosis. - Hypoechoic carotid plaque with a thickness of 2.5 mm at least. - Stable peripheral artery disease (PAD) defined as at least one of the following: * Previous revascularization with aorta-femoral bypass, infrainguinal bypass, thrombendarterectomy, thrombectomy, endovascular procedures or farmeceutical with heparine and/or thrombolysis. * Previous amputation of food or leg due to arteriel insufficiency. * Current of previous intermittent claudication with one or more of the following: ankle/brachial (ABI) index < 0.9 and/or significant peripheral arterial stenosis > 50% verificed by angiography or duplex ultrasound.
You likely can't join if
- General exclusion criteria: - Subjects who are pregnant, breastfeeding, or are of childbearing potential and sexually active and not practicing an effective method of contraception. - Severe cardiac insufficiency with ejection fraction < 30% or New York Heart Association (NYHA) Class III or IV symptoms. - Current acute condition/disease. CEUS exclusion criteria: - Previous allergic reaction towards the contrast SonoVue® - Electronic implantation e.g. pacemaker, ICD, due to use of magnetic field ultrasound. - Patients who cannot cooperate to the ultrasound examination. Rivaroxaban exclusion criteria: - Concomitant participation in another study with investigational drug. XML File Identifier: odUcQ2bKM/VFeYJoaZs9/VmaD9k= Page 11/24 - History of hypersensitivity or known contraindication for rivaroxaban, aspirin (acetylsalicyl acid), pantoprazole, or excipients. - Need for other anticoagulant therapy e.g. warferin or other direct oral anticoagulants than rivaroxaban. - Already in treatment with rivaroxaban. - Need for dual antiplatelets therapy or other non-aspirin antiplatelet therapy. - High risk of bleeding e.g.: active significant bleeding, previous or current lesions or conditions with significant risk of major bleedings, recent cerebral, spinal or ocular surgery, recent intracranial bleeding, esophageal varices, arteriovenous malformations, vascular aneurysms or majour intraspinal og intracerebral vascular abnormalities. - Stroke within 1 year or previous haemorrhagic or lacunar stroke. - Any known hepatic disease associated with coagulopathy. - Estimated glomerular filtration rate < 30 mL/min/m2 - Other severe, non-cardiovascular condition/disease associated with poor prognosis (e.g. metastatic cancer) and limits life expectancy. - Systemic treatment with strong inhibitors of CYP3A4 as well as pglycoprotein (e.g., systemic azole antimycotics, such as ketoconazole, and HIV-protease inhibitors, such as ritonavir). - Strong inducers of CYP3A4 (i.e., rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.