Rivaroxaban Versus Standard of Care for Patients With Excessive Atrial Ectopy or Short Atrial Runs and High Embolism Risk

Prior treatment

• According to the SmPC, any contraindication to Rivaroxaban (particularly patients with ongoing major bleeding, vascular complication, prior haemorrhagic stroke or over recent stroke) or one of its excipients.
• Patients with previous documented AF
• Anticoagulant agents in the month prior to the inclusion visit
• Ongoing need for strong inhibitors of both CYP3A4 and P-glycoprotein (e.g., ketoconazole, itraconazole, ritonavir or clarithromycin)
• Participants considered by the investigator to be unsuitable for the study for any of the following reasons:Patient refuse the treatment with rivaroxaban or anticipated to have poor compliance on study drug treatment or Unwilling to attend study follow-up visits
• Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
• Conditions associated with an increased risk of bleeding:
  • Major surgery within the previous month
  • Planned surgery or intervention within the next 3 months
  • History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
  • Gastrointestinal hemorrhage within the past year
  • Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days
  • Hemorrhagic disorder or bleeding diathesis
  • Need for anticoagulant treatment of disorders other than atrial fibrillation
  • Fibrinolytic agents within 48 hours of study entry
  • Uncontrolled hypertension (systolic blood pressure greater than 180 mm Hg and/or diastolic blood pressure greater than 100 mm Hg)
  • Recent malignancy or radiation therapy (within 6 months) and not expected to survive 3 years
• Patients who have received an investigational drug in the past 30 days

Other illness

• History of major hemorrhage after taking Rivaroxaban
• Valvular congenital heart disease
• Acute coronary syndrome, coronary revascularization (percutaneous coronary intervention or coronary artery bypass surgery) or in the past 30 days
• Cancer or other life threatening conditions
• Active liver disease, including but not limited to, associated or not with coagulopathy and a clinically significant risk of bleeding, including cirrhotic patients with a Child Pugh class B or C score.
• Known active hepatitis C (positive HCV RNA)
• Known active hepatitis B (HBs antigen +, anti HBc IgM +)
• Known active hepatitis A
• Patients considered unreliable by the investigator, or having any condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse)
• Patient with cardiac prosthetic devices : Reveal, pace-maker, automatic implantable defibrillator
• Persons under psychiatric care

Lab values

• Requires long-term antiplatelet therapy other than aspirin (i.e., patient requires any platelet aggregation inhibitor in addition to study treatment, in particular, the combination of two platelet aggregation inhibitors)
• Severe renal impairment (estimated creatinine clearance \<30 mL/min or less)
• Persistent ALT, AST, Alk Phos greater than twice the upper limit of the normal range
• Anemia (hemoglobin level less than 110 g/L) or thrombocytopenia (platelet count less than 150 X 109/L)

Other

• Inability to perform cerebral MRI
• Life expectancy \<24 months
• Documented atrial fibrillation or any other indication for oral anticoagulation
• Ongoing need for strong inducers of both CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin)
• Active infective endocarditis
• Participation in another interventional clinical trial
• Patient on AME (state medical aid)
• Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice)Patients deprived of their liberty by a judicial or administrative decision

• Patients ≥ 65 years old
• Diagnosis of excessive supraventricular ectopy activity defined as ≥ 1% PAC / 24 h or any atrial runs ≥ 20 PACs on a 24-hour Holter ECG monitoring (the indication for the Holter will be let at the discretion of the doctor according to international guidelines indication)
• High risk embolism defined by a CHA2DS2VASC score ≥ 3
• Written consent from patient
• Patients able to attend consultations and Cerebral MRI at baseline and 24 months at the participating centre.
• Ability to understand and comply with the study protocol
• Affiliation of social security regime