- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02043808
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
연구 개요
상태
정황
상세 설명
Study Design:
Retrospective
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Massachusetts
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Lexington, Massachusetts, 미국
- 1160.183.01 Boehringer Ingelheim Investigational Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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;
공부 계획
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디자인 세부사항
- 시간 관점: 회고전
코호트 및 개입
그룹/코호트 |
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다비가트란
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와파린
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Stroke (Hemorrhagic, Ischemic)
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Ischemic Stroke
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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).
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Death
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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