Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II) (ORBIT-AF II)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01701817|
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : July 21, 2020
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|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Other: Patients with Atrial Fibrillation|
|Study Type :||Observational|
|Actual Enrollment :||13769 participants|
|Official Title:||Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (Orbit-AF II)|
|Actual Study Start Date :||February 20, 2013|
|Actual Primary Completion Date :||July 12, 2017|
|Actual Study Completion Date :||July 12, 2017|
Patients with Atrial Fibrillation (AF)
(1) patients with new onset/first detected Atrial Fibrillation (AF) diagnosed within the 6 months preceding the baseline visit; or (2) patients with AF who had initiation or transition to a FXa (Factor Xa) inhibitor or a direct thrombin inhibitor within the preceding 3 months.
Other: Patients with Atrial Fibrillation
Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.
- Number of major bleeding events [ Time Frame: 2 years ]Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.
- Number of major adverse cardiac events [ Time Frame: 2 years ]Major cardiac events are defined as stroke or non-central nervous system (non-CNS) systemic embolism, myocardial infarction, and cardiovascular death.
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
Inclusion Criteria: - Adult patients with incident (initial diagnosis) AF (Atrial Fibrillation) with electrocardiographic documentation or patients with prevalent (existing diagnosis) AF who had initiation or transition to a 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701817
|Study Director:||Janssen Scientific Affairs, LLC Clinical Trial||Janssen Scientific Affairs, LLC|
|Responsible Party:||Janssen Scientific Affairs, LLC|
|Other Study ID Numbers:||
RIVAROXAFL4002 ( Other Identifier: Janssen Scientific Affairs, LLC )
|First Posted:||October 5, 2012 Key Record Dates|
|Last Update Posted:||July 21, 2020|
|Last Verified:||July 2020|
Irregular heart beat