Effectiveness and Safety of Low Dose Rivaroxaban Plus Aspirin in Patients With Chronic Coronary Syndrome and High Ischemic Risk

Dutch Rivaroxaban CCS Registry

Registry to describe the impact in terms of effectiveness and safety of the combination treatment of rivaroxaban 2.5 mg twice daily with aspirin on clinical outcomes and practices in a real-life Dutch patient population that are at high risk of ischemic events.

2020-12-21

2023-09-13

2023-09-13

Completed

645

Inclusion Criteria: * Adult (≥18 years) patient. * Diagnosis of CAD and/or PAD and high risk of ischemic events. * Patients at high risk of ischaemic events include the following: * CAD + PAD * CAD + Recurrent MI (Previous MI followed by second MI) * CAD + diabetes mellitus (all types) * CAD + chronic kidney disease with eGFR 30-59 ml/min/1.73 m2 (CKD-EPI formula) * CAD + heart failure (ejection fraction ≥30% - 50%) and New York Heart Association (NYHA) class I or II;) * CAD + CHA2DS2VaSc ≥ 3 (for men) or ≥ 4 (for women) * Patients can only be enrolled in the study if the decision to treat with rivaroxaban plus ASA has been made by the treating physician in advance and independent of study inclusion, however within 4 weeks prior to study inclusion. * Treatment according to local marketing authorization, with rivaroxaban 2.5 mg \[BID\] and 80mg ASA / 100mg Carbasalate calcium. Treatment of rivaroxaban started within 4 weeks prior or 4 weeks after study inclusion. * Patients who are willing to participate in this study (signed informed consent). Exclusion Criteria: * Hypersensitivity/allergy and known contraindication to ASA/Carbasalate calcium or rivaroxaban * Patients with recent major bleeding, active bleeding, or history with: * History of major clinical bleeding or known coagulopathy * History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke * Known severe liver dysfunction * Patients that have received any organ transplant or await any organ transplant * Patient with anemia (Hb \< 6.0 mmol/L) * Patient with active malignancy * Patients with ejection fraction \< 30% and/or New York Heart Association (NYHA) class III or IV * Patients with eGFR \< 30 ml/min/1.73m2 or undergoing dialysis * Patients with liver failure accompanied with coagulopathy ( incl. Child-Pugh B and C) * Patients with concomitant use of other anticoagulants or antiplatelet drugs * Pregnant or lactating female * Patients currently participating in another investigational drug or drug-coated device study

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '12 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 645, 'type': 'ACTUAL'}}

2023-09-28