Anticoagulant Utilization Pattern
26 mars 2019 mis à jour par: Boehringer Ingelheim
A Description of Warfarin and NOAC Utilization Patterns Including Initiation, Switching, and Discontinuation
This study plans to describe utilization patterns for oral anticoagulants over time in patients with non-valvular atrial fibrillation at risk for stroke using electronic claims data from a United States commercial insurance database.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Observationnel
Inscription (Réel)
333664
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
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Massachusetts
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Boston, Massachusetts, États-Unis, 02120
- Brigham and Women's Hospital
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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 et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Patients 18 years of age and older with non-valvular AF at risk for stroke treated with oral anticoagulation
La description
Inclusion criteria:
- A recorded diagnosis of atrial fibrillation
- Initiation of oral anticoagulant medication
- Congestive Heart Failure, Hypertension, Age > 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) Score >=1
- At least 18 years of age on the date of anticoagulant initiation
Exclusion criteria:
- Patients with missing or ambiguous age or sex information
- Patients with documented evidence of valvular disease
- Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the first dispensing
- Patients with prior use of any oral anticoagulant
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 |
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Dabigatran
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Warfarin or other New Oral Anticoagulant (NOAC)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Description of the Characteristics of Anticoagulant Initiators
Délai: From January 2009 to September 2015 (The study period)
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The analyses described the characteristics of patients treated with various oral anticoagulants.
CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender.
HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (>65 years), Drugs and Alcohol.
CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome.
New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above).
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From January 2009 to September 2015 (The study period)
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Percentage of Patients Initiating Specific Anticoagulant
Délai: From January 2009 to September 2015 (The study period)
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Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
This is related to UnitedHealth database and no treatment initiation rate was estimated in MarketScan as the study cohort was defined from a population of oral anticoagulants users.
The overall number of participants analyzed "609201" reported for each of the treatment arm below corresponds to overall patients numbers in UnitedHealth for the entire study period rather than for each of the treatment arm.
Likewise the number of participants for each of the treatment arm for different time period corresponds to the total number of participants for the specific study period rather than for each of the treatment arm.
Incident users at given time period could also be counted in later time period if the patient discontinued the drug and had re-entry during the study period.
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From January 2009 to September 2015 (The study period)
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Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran
Délai: From January 2009 to September 2015 (The study period)
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Percentage of patients initiating specific anticoagulant dose of dabigatran across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented.
Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
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From January 2009 to September 2015 (The study period)
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Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban
Délai: From January 2009 to September 2015 (The study period)
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Percentage of patients initiating specific anticoagulant dose of apixaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented.
Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
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From January 2009 to September 2015 (The study period)
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Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban
Délai: From January 2009 to September 2015 (The study period)
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Percentage of patients initiating specific anticoagulant dose of rivaroxaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented.
Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
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From January 2009 to September 2015 (The study period)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Treatment Persistence Over Time
Délai: From January 2009 to September 2015 (The study period)
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Overall treatment persistence in UnitedHealth and MarketScan cohorts are presented as the percentage of patients who were persistent to treatment after 3, 6 and 12 months of follow-up for all time periods combined and matched cohort.
Based on two US-based longitudinal healthcare claims databases (MarketScan and unitedHealth Research Database) the three separate study cohorts warfarin vs dabigatran, warfarin vs rivaroxaban and warfarin vs apixaban cohort were formed for each database.
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From January 2009 to September 2015 (The study period)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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)
17 avril 2013
Achèvement primaire (Réel)
1 novembre 2017
Achèvement de l'étude (Réel)
1 novembre 2017
Dates d'inscription aux études
Première soumission
18 avril 2013
Première soumission répondant aux critères de contrôle qualité
2 mai 2013
Première publication (Estimation)
7 mai 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 juin 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 mars 2019
Dernière vérification
1 mars 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1160.177
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