Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT06103266
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Successful PCI
* History of or newly diagnosed (\<72 hours after PCI/ACS) AF or atrial flutter with a long-term (≥ 1 year) indication for OAC
* Treatment with a loading dose of clopidogrel and aspirin prior to or during PCI
Exclusion Criteria:
* Known allergy or contraindication for rivaroxaban
* Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism)
* Overwriting indication for DAPT (e.g. TIA/CVA or PAD)
* Mechanical heart valve prosthesis
* Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)
* Intracardiac thrombus or apical aneurysm requiring OAC
* Kidney failure (eGFR \<15)
* Active liver disease (ALT, ASP, AP \>3x ULN or active hepatitis A, B or C)
* Active malignancy excluding non-melanoma skin cancer
* Active bleeding on randomization
* Severe anaemia requiring blood transfusion
* Pregnancy or breast-feeding women
* Planned high-bleeding risk surgical intervention within 6 months after PCI for stable CAD and 12 months after PCI for ACS
* PCI of left main disease, chronic total occlusion, bifurcation lesion requiring two-stent treatment, saphenous or arterial graft lesion, severely calcified lesions
* Participation in another trial with an investigational drug or device (i.e. stent)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06103266
Study Brief:
Protocol Section:
NCT06103266