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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043808
• Other study ID #: 1160.183
• Status: Completed
• Phase: N/A
• First received: January 10, 2014
• Last updated: July 1, 2015
• Start date: January 2014
• Est. completion date: May 2014

Study information

• Verified date: July 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Description:

Study Design:

Retrospective

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25586
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	1160.183.01 Boehringer Ingelheim Investigational Site	Lexington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke (Hemorrhagic, Ischemic)	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)	No
Primary	Major Bleeding	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)	Yes
Secondary	Ischemic Stroke	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)	No
Secondary	Hemorrhagic Stroke	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).	Yes
Secondary	Major Intracranial Bleeding	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).	Yes
Secondary	Major Extracranial Bleeding	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).	Yes
Secondary	Major GI Bleeding	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).	Yes
Secondary	Major Upper GI Bleeding	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).	Yes
Secondary	Major Lower GI Bleeding	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).	Yes
Secondary	Major Urogenital Bleeding	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).	Yes
Secondary	Major Other Bleeding	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).	Yes
Secondary	Transient Ischemic Attack	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).	No
Secondary	Myocardial Infarction	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).	No
Secondary	Venous Thromboembolism	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).	No
Secondary	Deep Vein Thrombosis	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).	No
Secondary	Pulmonary Embolism	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).	No
Secondary	Death	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).	No

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