Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy
NCT02921126
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- are at least 18 years of age at index date
- Initiated new OAC therapy ( no previous prescriptions of the same index OAC in the last 12 months prior to the index date ) during the study period
- Had at least 1 claim with diagnosis of AF anytime in their records
- Have a record that is indicative of Valvular Atrial Fibrillation during this period
- Have a history of the OACs prescribed during the study period as assessed during the
period of data availability(i.e. history of index OAC, as patients need to be newly
prescribed either apixaban, rivaroxaban, dabigatran or VKA)
- Have more than one OAC exposure which starts on the same date
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Descriptive Information | ||||
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Brief Title | Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy | |||
Official Title | Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy | |||
Brief Summary | To quantify rates of bleeding events and investigate the characteristics of prescribed patients, rates of bleeding events, persistence and healthcare resource utilization of Oral Anticoagulants (OACs) prescribed in routine clinical practice. | |||
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 | The study will include adults with NVAF who are newly prescribed apixaban, rivaroxaban, dabigatran, and VKA in 10 Italian Local Health Units (LHUs), during the study period, and meet the inclusion and exclusion criteria. | |||
Condition | Anticoagulation | |||
Intervention | Not Provided | |||
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 | Completed | |||
Actual Enrollment | 9914 | |||
Original Estimated Enrollment | 40900 | |||
Actual Study Completion Date | August 2, 2018 | |||
Actual Primary Completion Date | August 2, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
| |||
Ages | 18 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 | Italy | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT02921126 | |||
Other Study ID Numbers | CV185-494 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
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 | August 2018 |