Rivaroxaban for Acute coronary syndrome | Atrial fibrillation

Inclusion criteria

• {"criterion_text":"- Patients, aged ≥18.\n- Hospitalization for acute coronary syndrome with or without ST segment elevation\n- Atrial fibrillation present at the time of patient arrival at the hospital or occurring at any time during hospitalization. Patient without any prior known history of arrhythmia.\n- Chads2vas SCORE ≥ 1 for men and ≥ 2 for women\n- Ablation of atrial fibrillation before enrollment in the study. The atrial fibrillation ablation can be spontaneous or obtained by treatment\n- Coronary angioplasty with stenting should be done during the hospitalization"}

Exclusion criteria

• {"criterion_text":"- Atrial fibrillation diagnosed before hospitalization for acute coronary syndrome, whether treated or not\n- Atrial fibrillation still present at inclusion time\n- Patient already on anticoagulant therapy\n- Creatinine clearance < 30 ml per minute\n- Contraindications to anticoagulant therapy\n- Active internal hemorrhage, clinically significant bleeding, bleeding non accessible to compression or bleeding diathesis within 30 days prior to selection visit"}

Primary endpoints

• {"endpoint_text":"- Occurrence during the 2 years of follow-up of a bleeding event defined by a score ≥2 according to the BARC scale","definition_or_measurement_approach":"Defined by a score ≥2 according to the BARC scale occurring during 2 years of follow-up."}

Secondary endpoints

• {"endpoint_text":"- Occurrence of an event defined by the MACCE indicator","definition_or_measurement_approach":"Occurrence via the MACCE composite indicator (as described: death, stroke or systemic embolism, non-fatal infarction and need for revascularization)."}
• {"endpoint_text":"- Occurrence of an ischemic event defined by the following composite indicator: death from cardiovascular causes, stroke or systemic embolism, non-fatal infarction and need for revascularization","definition_or_measurement_approach":"Composite indicator: death from cardiovascular causes, stroke or systemic embolism, non-fatal infarction and need for revascularization."}

France

Earliest CTIS Part Ii Submission Date

20-12-2024

Latest Decision Or Authorization Date

25-07-2025

Processing Time Days

217

Number Of Sites

15

Number Of Participants

100

Primary sponsor

Full Name

Centre Hospitalier De Pau

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France