Evaluation of Safety and Effectiveness on Oral Anticoagulants
NCT03765242
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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 | |||||
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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 |
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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 |
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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 |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Bristol-Myers Squibb | ||||
Study Sponsor | Bristol-Myers Squibb | ||||
Collaborators | Pfizer | ||||
Investigators |
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PRS Account | Bristol-Myers Squibb | ||||
Verification Date | December 2018 |