Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT02687867
Eligibility Criteria:
Inclusion Criteria:
* Non-valvular atrial fibrillation will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD-9 427.31 (International Classification of Disease, Ninth Revision, Clinical Modification) as the diagnosis code at any time in the patient's data history prior to inclusion
* Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics
* CHA2DS2-Vasc (Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category ) score ≥2 during the 180 days prior to index dabigatran use baseline period
Exclusion Criteria:
* Patients \<18 years of age
* Patients with valvular Atrial fibrillation
* Pregnancy
* Malignant cancers
* Transient cause of Atrial fibrillation
* Patients with Venous thromboembolism (pulmonary embolism or Deep Vein Thrombosis)
* Patients with major surgery defined as hip or knee replacement
* Prescriptions of Oral anticoagulants (OACs) {apixaban, warfarin, dabigatran, rivaroxaban} before index date
* Prescription of more than one OAC on the index date
* Patient with any of the events defined in the composite endpoint
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02687867
Study Brief:
Protocol Section:
NCT02687867