Rivaroxaban for Carotid artery atherosclerosis | Peripheral artery disease

Inclusion criteria

• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"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)."}

Primary endpoints

• {"endpoint_text":"- More hyperechoic carotid plaques in the intervention group, with 1 year rivaroxaban treatment, compared to placebo over time determined by increase in plaque echogenicity with at least 20 % in grey-median-scale (GSM) registered by ultrasound, as an expression of plaque stabilizaton by rivaroxaban.","definition_or_measurement_approach":"Increase in plaque echogenicity of at least 20% in grey-median-scale (GSM) registered by 3D contrast-enhanced ultrasound over 1 year of rivaroxaban treatment compared to placebo."}

Secondary endpoints

• {"endpoint_text":"- volumen, thrombus volumen and intraplaque contrastfilling over time in the intervention-rivaroxaban group compared to placebo. 2) Secondary major events endpoints including but not necessary limited to: - Death (all cause mortality). - MACE (Major Adverse Cardiovascular Events): myocardial infarction, stroke, cardiovascular death. - MALE (Major Adverse Limb Events) e.g. acute og chronic critical limb ischaemia and including amputation above the ankle. - Transient ischaemic attack (TIA) - Major b","definition_or_measurement_approach":"Ultrasound-assessed plaque volume, thrombus volume and intraplaque contrast-filling over time; clinical event outcomes including death (all-cause), MACE (myocardial infarction, stroke, cardiovascular death), MALE (major adverse limb events including amputation above the ankle), transient ischemic attack (TIA) and other major events as listed."}

Denmark

Earliest CTIS Part Ii Submission Date

17-10-2024

Latest Decision Or Authorization Date

27-10-2024

Processing Time Days

10

Number Of Sites

1

Number Of Participants

62

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"","full_name":"Bayer AG","duties_or_roles":"Source of monetary support","organisation_type":""}