Rivaroxaban for Coronary artery disease | Atrial fibrillation | Percutaneous coronary intervention

Inclusion criteria

• {"criterion_text":"- Age ≥18 years\n- Successful PCI\n- History of or newly diagnosed (<72 hours after PCI/ACS) AF or atrial flutter with a long-term (≥ 1 year) indication for OAC\n- Treatment with a loading dose of clopidogrel prior to or during PCI"}

Exclusion criteria

• {"criterion_text":"- Known allergy or contraindication for rivaroxaban\n- Mechanical heart valve prosthesis\n- Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)\n- Intracardiac thrombus or apical aneurysm requiring OAC\n- Kidney failure (eGFR <15)\n- Active liver disease (ALT, ASP, AP >3x ULN or active hepatitis A, B or C)\n- Active malignancy excluding non-melanoma skin cancer\n- Suboptimal stenting result based on angiographic and optional intra-coronary imaging input\n- Systemic treatment with strong inhibitors or inducers of both cytochrome P450 (CYP) 3A4 and p-glycoproteine (P-gp; e.g. ketoconazole or carbamazepine)\n- Active bleeding on randomization\n- Severe anaemia requiring blood transfusion\n- Pregnancy or breast-feeding women\n- Planned high-bleeding risk surgical intervention within 6 months after PCI for stable CAD and 12 months after PCI for ACS\n- PCI of left main disease, chronic total occlusion, bifurcation lesion requiring two-stent treatment, saphenous or arterial graft lesion, severely calcified lesions\n- Participation in another trial with an investigational drug or device (i.e. stent\n- Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism)\n- Overwriting indication for DAPT (e.g. TIA/CVA or PAD)"}

Primary endpoints

• {"endpoint_text":"- The primary ischemic endpoints at 6 months is the composite of all-cause mortality, myocardial infarction (according to the 4th universal definition of MI), Academic Research Consortium (ARC) defined definite stent thrombosis, or ischemic stroke","definition_or_measurement_approach":"Composite at 6 months including all-cause mortality; myocardial infarction defined according to the 4th universal definition of MI; Academic Research Consortium (ARC) defined definite stent thrombosis; ischemic stroke"}
• {"endpoint_text":"- The primary bleeding endpoint at 6 months is major bleeding or clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) criteria","definition_or_measurement_approach":"Bleeding at 6 months classified as major bleeding or clinically relevant non-major bleeding per ISTH criteria"}

Netherlands

Earliest CTIS Part Ii Submission Date

26-02-2024

Latest Decision Or Authorization Date

15-05-2024

Processing Time Days

79

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands