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The Comparative Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-valvular Atrial Fibrillation Population With Humana Healthcare Coverage

7 juin 2017 mis à jour par: Boehringer Ingelheim

The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Humana Non-Valvular Atrial Fibrillation (NVAF) Patient Population-A Retrospective Database Analysis

This study is an opportunity for Boehringer Ingelheim to collaborate with Humana to conduct comparative safety and effectiveness studies of dabigatran and warfarin using real world data from Humana's health plan operations.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Study Design:

n/a

Type d'étude

Observationnel

Inscription (Réel)

38499

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Kentucky
      • Louisville, Kentucky, États-Unis, 40202
        • Comprehensive Health Insights, Louisville

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 89 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

NVAF

La description

Inclusion criteria:

  • Patient must have at least one inpatient, one physician office visit, or one emergency room visit with a diagnosis of AF on the index date or during the pre-index period.
  • Patients must be continuously enrolled in a health plan during the pre-index period
  • Patient must have a prescription for dabigatran or warfarin
  • Patient must be treatment naive from all oral anticoagulant (OAC) use prior to first OAC prescription
  • Aged 18-89 years on the index date. The index date is defined as the date of the first OAC prescription

Exclusion criteria:

  • Diagnosis of hyperthyroidism during the pre-index period,
  • Having claims for any of the following within 3 months prior to the first diagnosis of AF: cardiac surgery, pericarditis, myocarditis, pulmonary embolism.
  • Any patients with at least one medical claim for valvular heart disease.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
dabigatran
Médicament: Observational
Retrospective Chart Review
warfarin

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Stroke (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the primary analysis.

Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy.

Hemorrhagic stroke includes: Subarachnoid hemorrhage (SAH) and Intracerebral hemorrhage (ICH) but excludes previous listed diagnoses if "traumatic brain injury" or "rehabilitation care" is present.

Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Stroke (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Major Bleeding (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of major bleeding (hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the primary analysis.

Major Intracranial Bleeding includes subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid hemorrhage following injury without mention of open intracranial wound, subdural hemorrhage following injury without mention of open intracranial wound, extradural hemorrhage following injury without mention of open intracranial wound, other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if major trauma was present. Major extracranial bleeding includes major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding. Either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization were used.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Major Bleeding (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
This outcome measure describes the incidence of major bleeding (Inclusive of hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Ischemic Stroke (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of ischemic stroke for dabigatran and warfarin in the primary analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy.

Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Ischemic Stroke (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of ischemic stroke for dabigatran and warfarin in the post-hoc analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy.

A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Hemorrhagic Stroke (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of hemorrhagic stroke for dabigatran and warfarin in the primary analysis. Hemorrhagic stroke includes: subarachnoid hemorrhage, intracerebral hemorrhage but excludes these codes if "traumatic brain injury" or "rehabilitation care" as primary code is present.

Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Hemorrhagic Stroke (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of hemorrhagic stroke for dabigatran and warfarin in the post-hoc analysis. Hemorrhagic stroke includes: Subarachnoid hemorrhage and intracerebral hemorrhage but excludes these codes if "traumatic brain injury" or "rehabilitation care" as primary code is present.

A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Major Intracranial Bleeding (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of major intracranial bleeding for dabigatran and warfarin in the primary analysis. Major intracranial bleeding includes: Subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid, subdural or extradural hemorrhage following injury without mention of open intracranial wound other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if concomitant discharge diagnosis of major trauma was present.

Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Major Intracranial Bleeding (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of major intracranial bleeding for dabigatran and warfarin in the post-hoc analysis. Major intracranial bleeding includes: Subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid, subdural or extradural hemorrhage following injury without mention of open intracranial wound other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if concomitant discharge diagnosis of major trauma was present.

A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Major Extracranial Bleeding (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of major extracranial bleeding for dabigatran and warfarin in the primary analysis. Major extracranial bleeding includes: major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding.

Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Major Extracranial Bleeding (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of major extracranial bleeding for dabigatran and warfarin in the post-hoc analysis. Major extracranial bleeding includes: major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding.

A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Major GI Bleeding (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of major GI bleeding for dabigatran and warfarin in the primary analysis. Major GI bleeding includes major upper GI bleeding and major lower GI bleeding.

Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Major GI Bleeding (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of major GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major GI bleeding includes major upper GI bleeding and major lower GI bleeding.

A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Major Upper GI Bleeding (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
This outcome measure describes the incidence of major upper GI bleeding for dabigatran and warfarin in the primary analysis. Major upper GI bleeding includes acute gastric ulcer, chronic or unspecified gastric ulcer, acute duodenal ulcer, chronic or unspecified duodenal ulcer, acute, chronic or unspecified peptic ulcer, acute gastrojejunal ulcer, chronic or unspecified gastrojejunal ulcer with hemorrhage with/without obstruction and with hemorrhage and perforation with/without obstruction, hematemesis, endoscopic control of gastric or duodenal bleeding, upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Major Upper GI Bleeding (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
This outcome measure describes the incidence of major upper GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major upper GI bleeding includes acute, chronic or unspecified gastric ulcer, acute duodenal ulcer, chronic or unspecified duodenal ulcer, acute, chronic or unspecified peptic ulcer, acute, chronic or unspecified gastrojejunal ulcer with hemorrhage with/without (w/wo) obstruction and with hemorrhage and perforation w/wo obstruction, hematemesis, endoscopic control of gastric or duodenal bleeding, upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. This was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Major Lower GI Bleeding (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of major lower GI bleeding for dabigatran and warfarin in the primary analysis. Major lower GI bleeding includes diverticulosis or diverticulitis of small intestine or of colon with hemorrhage, hemorrhage of rectum and anus, angiodysplasia of intestine with hemorrhage, blood in stool and hemorrhage of GI tract (unspecified).

Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Major Lower GI Bleeding (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of major lower GI bleeding for dabigatran and warfarin in the post-hoc analysis.

Major lower GI bleeding includes diverticulosis or diverticulitis of small intestine or of colon with hemorrhage, hemorrhage of rectum and anus, angiodysplasia of intestine with hemorrhage, blood in stool and hemorrhage of GI tract (unspecified).

A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Major Urogenital Bleeding (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of major urogenital bleeding for dabigatran and warfarin in the primary analysis. Major urogenital bleeding includes hematuria and excessive/frequent menstruation and secondary diagnosis indicating acute bleeding (anemia).

Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Major Urogenital Bleeding (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of major urogenital bleeding for dabigatran and warfarin in the post-hoc analysis.

Major urogenital bleeding includes hematuria and excessive/frequent menstruation and secondary diagnosis indicating acute bleeding (anemia).

A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Other Major Bleeds (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of other major bleeds for dabigatran and warfarin in the primary analysis. Other major bleeds includes hemarthrosis, hemopericardium, hemoptysis, epistaxis, hemorrhage (not specified) and acute posthemorrhagic anemia.

Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Other Major Bleeds (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of other major bleeds for dabigatran and warfarin in the post-hoc analysis.

Other major bleeds includes hemarthrosis, hemopericardium, hemoptysis, epistaxis, hemorrhage (not specified) and acute posthemorrhagic anemia.

A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Transient Ischemic Attack (TIA) (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of TIA for dabigatran and warfarin in the primary analysis. TIA includes transient cerebral ischemia as the principal (primary) discharge diagnosis.

Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
TIA (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of TIA for dabigatran and warfarin in the post-hoc analysis.

TIA includes transient cerebral ischemia as the principal (primary) discharge diagnosis.

A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Myocardial Infarction (MI) (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
This outcome measure describes the incidence of MI for dabigatran and warfarin in the primary analysis. MI includes the acute myocardial infarction. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
MI (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of MI for dabigatran and warfarin in the post-hoc analysis.

MI includes the acute myocardial infarction. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Venous Thromboembolism (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of venous thromboembolism for dabigatran and warfarin in the primary analysis. Venous thromboembolism includes the deep vein thrombosis and the pulmonary embolism.

Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Venous Thromboembolism (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of venous thromboembolism for dabigatran and warfarin in the post-hoc analysis.

Venous thromboembolism includes the deep vein thrombosis and the pulmonary embolism.

A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Deep Vein Thrombosis (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
This outcome measure describes the incidence of deep vein thrombosis for dabigatran and warfarin in the primary analysis. Deep vein thrombosis includes phlebitis and thrombophlebitis and other venous embolism and thrombosis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Deep Vein Thrombosis (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of deep vein thrombosis for dabigatran and warfarin in the post-hoc analysis.

Deep vein thrombosis includes phlebitis and thrombophlebitis and other venous embolism and thrombosis.

A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Pulmonary Embolism (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
This outcome measure describes the incidence of pulmonary embolism for dabigatran and warfarin in the primary analysis. Pulmonary embolism includes acute pulmonary heart disease. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Pulmonary Embolism (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of pulmonary embolism for dabigatran and warfarin in the post-hoc analysis.

Pulmonary embolism includes acute pulmonary heart disease. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
All-cause Death (Primary Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
This outcome measure describes the incidence of death for dabigatran and warfarin in the primary analysis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
All-cause Death (Post-hoc Analysis)
Délai: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

This outcome measure describes the incidence of death for dabigatran and warfarin in the post-hoc analysis.

A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Boehringer Ingelheim

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

28 octobre 2014

Achèvement primaire (Réel)

15 mars 2016

Achèvement de l'étude (Réel)

15 mars 2016

Dates d'inscription aux études

Première soumission

12 février 2014

Première soumission répondant aux critères de contrôle qualité

12 février 2014

Première publication (Estimation)

13 février 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 juin 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 juin 2017

Dernière vérification

1 juin 2017

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1160.192

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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