Inclusion and exclusion criteria set the boundaries for the systematic review. They are determined after setting the research question usually before the search is conducted, however scoping searches may need to be undertaken to determine appropriate criteria. Many different factors can be used as inclusion or exclusion criteria. Information about the inclusion and exclusion criteria is usually recorded as a paragraph or table within the methods section of the systematic review. It may also be necessary to give the definitions, and source of the definition, used for particular concepts in the research question (e.g. adolescence, depression).
Other inclusion/exclusion criteria can include the sample size, method of sampling or availability of a relevant comparison group in the study. Where a single study is reported across multiple papers the findings from the papers may be merged or only the latest data may be included.
Men or women aged ≥18 years with non-valvular atrial fibrillation
Atrial fibrillation must be documented by electrocardiogram (ECG) evidence (e.g., 12-lead ECG, rhythm strip, Holter, pacemaker interrogation) within 30 days before randomization. In addition, subjects must have medical evidence of atrial fibrillation within one year before and at least one day before the qualifying ECG evidence. This could be obtained from a notation in the subject's record (e.g., medical chart, hospital discharge summary).
Subjects with newly diagnosed atrial fibrillation are eligible, provided that:
there is evidence that the atrial fibrillation is non-valvular
cardioversion is not planned
there is ECG evidence on two occasions, 24 hours apart, demonstrating atrial fibrillation
History of prior ischemic stroke, transient ischemic attack, or non-central nervous system (CNS) systemic embolism believed to be cardioembolic in origin or has two or more of the following risk factors:
heart failure and/or left ventricular ejection fraction ≤ 35%
hypertension (defined as use of antihypertensive medications within six months before the screening visit or persistent systolic blood pressure above 140 mmHg or diastolic blood pressure above 90 mmHg)
age ≥ 75 years
diabetes mellitus (defined as a history of type 1 or type 2 diabetes mellitus or use of antidiabetic medications within six months before screening visit)
Female subjects must be postmenopausal (for at least two years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, have a negative serum β-hCG pregnancy test at screening.
Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
In order to participate in the optional pharmacogenomic component, subjects must have signed the informed consent for DNA research document indicating willingness to participate in the pharmacogenomics component of the study (where local regulations permit).