The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage
The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation (NVAF) Patient Population-A Retrospective Database Analysis
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Study Design:
Retrospective
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Massachusetts
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Lexington, Massachusetts, Forenede Stater
- 1160.183.01 Boehringer Ingelheim Investigational Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion criteria:
- Patients must be continuously enrolled in a health plan during the pre-index period;
- Patients must have at least one inpatient, or one physician office visit, emergency room visit with a diagnosis of AF (ICD-9-CM diagnosis code: 427.31in any position) on the index date or during the pre-index period;
- Patients must have a prescription for dabigatran or warfarin (this first prescription will be the index date);
- Patients must be treatment naive from all OAC use prior to first dabigatran or warfarin prescription;
- Aged 18-89 on the index date;
Exclusion criteria:
- Patients with valvular procedures related to the baseline AF diagnosis will be excluded;
- Patients with transient causes of AF such as hyperthyroidism, any cardiac surgery, pericarditis, mycoarditis, pulmonary embolism within 3 months prior to their first diagnosis of AF;
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Dabigatran
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Warfarin
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Stroke (Hemorrhagic, Ischemic)
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period)
|
Event rate of stroke (hemorrhagic, ischemic). Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period)
|
|
Major Bleeding
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period)
|
Event rate of major bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Ischemic Stroke
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period)
|
Event rate of ischemic stroke. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period)
|
|
Hemorrhagic Stroke
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period).
|
Event rate of hemorrhagic stroke. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period).
|
|
Major Intracranial Bleeding
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period).
|
Event rate of major intracranial bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period).
|
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Major Extracranial Bleeding
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period).
|
Event rate of major extracranial bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period).
|
|
Major GI Bleeding
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period).
|
Event rate of major gastrointestinal (GI) bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period).
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Major Upper GI Bleeding
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period).
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Event rate of major upper gastrointestinal (GI) bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period).
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Major Lower GI Bleeding
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period).
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Event rate of major lower gastrointestinal (GI) bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period).
|
|
Major Urogenital Bleeding
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period).
|
Event rate of major urogenital bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period).
|
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Major Other Bleeding
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period).
|
Event rate of major other bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period).
|
|
Transient Ischemic Attack
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period).
|
Event rate of transient ischemic attacks. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period).
|
|
Myocardial Infarction
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period).
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Event rate of myocardial infarction. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period).
|
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Venous Thromboembolism
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period).
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Event rate of venous thromboembolism. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period).
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Deep Vein Thrombosis
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period).
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Event rate of deep vein thrombosis. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period).
|
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Pulmonary Embolism
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period).
|
Event rate of pulmonary embolism. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period).
|
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Death
Tidsramme: From October 1, 2009 through July 31, 2013 (the study period).
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Event rate of death, due to any cause. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
From October 1, 2009 through July 31, 2013 (the study period).
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1160.183
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