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
Přehled studie
Postavení
Podmínky
Detailní popis
Study Design:
Retrospective
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Massachusetts
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Lexington, Massachusetts, Spojené státy
- 1160.183.01 Boehringer Ingelheim Investigational Site
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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;
Studijní plán
Jak je studie koncipována?
Detaily designu
- Časové perspektivy: Retrospektivní
Kohorty a intervence
Skupina / kohorta |
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Dabigatran
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Warfarin
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Stroke (Hemorrhagic, Ischemic)
Časové okno: From October 1, 2009 through July 31, 2013 (the study period)
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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)
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Major Bleeding
Časové okno: From October 1, 2009 through July 31, 2013 (the study period)
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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)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Ischemic Stroke
Časové okno: From October 1, 2009 through July 31, 2013 (the study period)
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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)
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Hemorrhagic Stroke
Časové okno: From October 1, 2009 through July 31, 2013 (the study period).
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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).
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Major Intracranial Bleeding
Časové okno: From October 1, 2009 through July 31, 2013 (the study period).
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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
Časové okno: From October 1, 2009 through July 31, 2013 (the study period).
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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).
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Major GI Bleeding
Časové okno: From October 1, 2009 through July 31, 2013 (the study period).
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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
Časové okno: 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
Časové okno: 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).
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Major Urogenital Bleeding
Časové okno: From October 1, 2009 through July 31, 2013 (the study period).
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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
Časové okno: From October 1, 2009 through July 31, 2013 (the study period).
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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).
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Transient Ischemic Attack
Časové okno: From October 1, 2009 through July 31, 2013 (the study period).
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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).
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Myocardial Infarction
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: From October 1, 2009 through July 31, 2013 (the study period).
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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
Časové okno: 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).
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1160.183
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