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The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage

1 de julho de 2015 atualizado por: Boehringer Ingelheim

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

The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

Study Design:

Retrospective

Tipo de estudo

Observacional

Inscrição (Real)

25586

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Massachusetts
      • Lexington, Massachusetts, Estados Unidos
        • 1160.183.01 Boehringer Ingelheim Investigational Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

NVAF

Descrição

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;

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Perspectivas de Tempo: Retrospectivo

Coortes e Intervenções

Grupo / Coorte
Dabigatrana
Varfarina

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Stroke (Hemorrhagic, Ischemic)
Prazo: 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
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Ischemic Stroke
Prazo: 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
Prazo: 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
Prazo: 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).
Major Extracranial Bleeding
Prazo: 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
Prazo: 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).
Major Upper GI Bleeding
Prazo: From October 1, 2009 through July 31, 2013 (the study period).

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).
Major Lower GI Bleeding
Prazo: From October 1, 2009 through July 31, 2013 (the study period).

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
Prazo: 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).
Major Other Bleeding
Prazo: 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
Prazo: 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
Prazo: From October 1, 2009 through July 31, 2013 (the study period).

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).
Venous Thromboembolism
Prazo: From October 1, 2009 through July 31, 2013 (the study period).

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).
Deep Vein Thrombosis
Prazo: From October 1, 2009 through July 31, 2013 (the study period).

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).
Pulmonary Embolism
Prazo: 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).
Death
Prazo: From October 1, 2009 through July 31, 2013 (the study period).

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).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Boehringer Ingelheim

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2014

Conclusão Primária (Real)

1 de maio de 2014

Conclusão do estudo (Real)

1 de maio de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

10 de janeiro de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de janeiro de 2014

Primeira postagem (Estimativa)

23 de janeiro de 2014

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

3 de julho de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de julho de 2015

Última verificação

1 de julho de 2015

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 1160.183

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