Clinical Drug Experience Knowledgebase

Criteria

For entry into the study, the following criteria must be met:

Inclusion Criteria:

Age at consent ≥30 to ≤62 years;
Non-valvular atrial fibrillation (paroxysmal, persistent or permanent) documented by any electrical tracing or any device (i.e. routine 12-lead electrocardiogram, Holter monitor [continuous ECG recording] rhythm strip, intracardiac electrogram, or pacemaker or implantable cardiac defibrillator interrogation of at least 30 s, transcutaneous monitoring or other) in the last 2 years;

Low risk of stroke as defined by the absence of all of the following:

i. Prior stroke or Transient Ischemic Attack, ii. Hypertension, iii. Diabetes mellitus, iv. Congestive heart failure (New York Heart Association class II or higher at the time of enrolment or a known left ventricular ejection fraction <35%);

Signed informed consent

For entry into the study, none of the following criteria MUST be met

Exclusion Criteria:

Known diagnosis of dementia;
MMSE score <25;
Valvular AF [mechanical heart valve, moderate to severe mitral stenosis (rheumatic or non rheumatic), or hypertrophic cardiomyopathy];
Other indication for antiplatelet therapy or anticoagulation;
History of GI bleeding;

Conditions associated with an increased risk of bleeding described as follows:

Major surgery within the previous month;
Planned surgery or intervention within the next 3 months;
History of intracranial, intraocular, spinal, retroperitoneal or a traumatic intra-articular bleeding;
Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days;
Haemorrhagic disorder or bleeding diathesis;
Fibrinolytic agents within 48 hours of study entry;
Recent malignancy or radiation therapy (within 6 months from the time of enrolment) and not expected to survive 3 years;
Reversible cause of AF (e.g. cardiac surgery, pulmonary embolism, untreated hyperthyroidism);
Absence of recurrence of AF 3 months after AF ablation;
Severe renal impairment (creatinine clearance 30 mL/min or less);
Active infective endocarditis;
Active liver disease (e.g. acute clinical hepatitis, chronic active hepatitis, cirrhosis), or Alanine Transaminase (ALT) >3 times the upper limit of normal;
Women who are pregnant or of childbearing potential not using a medically acceptable form of contraception throughout the study;
Women who are breastfeeding;
Anemia or thrombocytopenia (according to the normal range values of the local laboratory);
Participation in another study involving an investigational drug (under development) at the same time or within 30 days of randomization;
Subjects considered unreliable, or having a life expectancy of less than 3 years 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);
History of allergic reaction to rivaroxaban.
History of allergic reaction, in the absence of desensitization to acetylsalicylic acid in patients with vascular disease.