Evaluation of Safety and Effectiveness on Oral Anticoagulants
NCT03765242
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Individuals greater than or equal to 20 years old as of the index date
- At least 1 diagnosis of NVAF prior to or on index date, identified by any medical records
- Newly treated with warfarin or apixaban between 01-Jan-2011 to 31-Dec-2016. The first warfarin or apixaban prescription date during the identification period will be designated as the index date
- Patient's medical records indicating pregnancy during the follow-up period
- Patient's medical records indicating taking warfarin, apixaban, dabigatran,
rivaroxaban, or edoxaban during the 6-months prior to the index date
- Had > 1 OAC prescription in the patient's medical records on the index date
Other protocol defined inclusion/exclusion criteria could apply
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Evaluation of Safety and Effectiveness on Oral Anticoagulants | ||||
| Official Title | Retrospective Medical Chart Review Study for Atrial Fibrillation Patents Treated With Oral Anticoagulant | ||||
| Brief Summary | This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients' medical charts with newly initiating warfarin or apixaban within the identification period fulfilling the study eligibility criteria | ||||
| Condition | Atrial Fibrillation | ||||
| Intervention | Other: Non-Interventional
Non-Interventional | ||||
| Study Groups/Cohorts |
| ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status | Active, not recruiting | ||||
| Estimated Enrollment | 12000 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 29, 2021 | ||||
| Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply | ||||
| Sex/Gender |
| ||||
| Ages | 20 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Japan | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03765242 | ||||
| Other Study ID Numbers | CV185-698 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
| ||||
| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Bristol-Myers Squibb | ||||
| Study Sponsor | Bristol-Myers Squibb | ||||
| Collaborators | Pfizer | ||||
| Investigators |
| ||||
| PRS Account | Bristol-Myers Squibb | ||||
| Verification Date | December 2018 | ||||