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

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02043808
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Study Design:

Retrospective

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2015-05-22
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-01
• Last Update Submitted: 2015-07-01
• Results First Posted: 2015-07-03
• Last Update Posted: 2015-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25586

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stroke (Hemorrhagic, Ischemic)	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.
Major Bleeding	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.

Secondary Outcome Measures

Name	Time	Method
Ischemic Stroke	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.
Hemorrhagic Stroke	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.
Major Intracranial Bleeding	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.
Major Extracranial Bleeding	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.
Major GI Bleeding	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.
Major Upper GI Bleeding	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.
Major Lower GI Bleeding	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.
Major Urogenital Bleeding	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.
Major Other Bleeding	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.
Venous Thromboembolism	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.
Transient Ischemic Attack	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.
Myocardial Infarction	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.
Deep Vein Thrombosis	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.
Pulmonary Embolism	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.
Death	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.

Trial Locations

Locations (1)

1160.183.01 Boehringer Ingelheim Investigational Site; 🇺🇸 Lexington, Massachusetts, United States