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The purpose of this study is to provide real-world data useful to address the factors associated to the administration of oral anticoagulants in the elderly population affected by non-valvular atrial fibrillation (NVAF), in Italy, and it's persistence rate after one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Non-valvular atrial fibrillation (NVAF) participants administered oral anticoagulants (OAs) | ||
| Cohort 2 | Non-valvular atrial fibrillation (NVAF) participants not administered oral anticoagulants |
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| Measure | Description | Time Frame |
|---|---|---|
| Anticoagulant (OA) cohort: Distribution of participants starting any type of anticoagulant direct-acting oral anticoagulant (DOAC) or Vitamin K antagonist (VKA) treatment | At Enrollment, up to 12 months | |
| Non-Anticoagulant (Not-OA) cohort: Distribution of participants not starting any type of anticoagulant (DOAC) or (VKA) treatment | At Enrollment, up to 12 months | |
| Treatment switch: Change of antithrombotic drug (in terms of active principle) during the 12-month observational period | Up to approximately 12 months | |
| Distribution of participants with persistence to the first treatment strategy: No switches nor interruptions of greater than 60 days in the first administered antithrombotic strategy (including no treatments) during the 12-month observational period | Up to approximately 12 months | |
| Distribution of participants with net clinical outcomes defined as occurrence of stroke, systemic embolism, major bleeding or death | Up to approximately 12 months |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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The study target population will be composed of elderly participants with diagnosis of Non-valvular atrial fibrillation (NVAF), managed in Italian geriatric departments/clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Milan | MI | 20144 | Italy |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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