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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 июля 2015 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Подробное описание

Study Design:

Retrospective

Тип исследования

Наблюдательный

Регистрация (Действительный)

25586

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

NVAF

Описание

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;

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Временные перспективы: Ретроспектива

Когорты и вмешательства

Группа / когорта
Дабигатран
Варфарин

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Stroke (Hemorrhagic, Ischemic)
Временное ограничение: 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
Временное ограничение: 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)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Ischemic Stroke
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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).

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Boehringer Ingelheim

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 января 2014 г.

Первичное завершение (Действительный)

1 мая 2014 г.

Завершение исследования (Действительный)

1 мая 2014 г.

Даты регистрации исследования

Первый отправленный

10 января 2014 г.

Впервые представлено, что соответствует критериям контроля качества

21 января 2014 г.

Первый опубликованный (Оценивать)

23 января 2014 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

3 июля 2015 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

1 июля 2015 г.

Последняя проверка

1 июля 2015 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 1160.183

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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