A Registry for Evaluating the Outcomes Associated with New Drug Treatments for Atrial Fibrillation, as Used in Broad Populations Outside of Clinical Trials
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
NCT ID: NCT01701817
Sponsor Protocol Number: RIVAROXAFL4002
About this study
The purpose of this registry is to collect observational data for evaluating the outcomes related to the use of new target-specific antithrombotic agents, such as FXa (factor Xa) inhibitors and direct thrombin inhibitors, as they are used in broad patient populations following approval by clinical research studies. The ORBIT-AF II registry will focus on patients with newly diagnosed atrial fibrillation (AF) as well as those who have been recently started on a target-specific oral anticoagulant agent.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adult patients with initial diagnosis of Atrial Fibrillation, with electrocardiographic documentation
- Patients with an existing diagnosis of AF who had initiation or transition to an FXa (Factor Xa) inhibitor or a direct thrombin inhibitor within the preceding 3 months
- Anticipated ability to adhere to local regularly scheduled follow-up visits
Exclusion Criteria:
- Atrial flutter only
- Anticipated life expectancy less than 6 months
- Short lasting AF secondary to a reversible condition (e.g. hyperthyroidism, pulmonary embolism, post-cardiothoracic surgery)
- Participation in a randomized trial of anticoagulation for AF at the time of enrollment
- Was enrolled in the ORBIT-I Registry
More information
Publications
Publications are currently not available