Clinical trial NCT02043808: The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-01-23
Enrollment: 25586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NVAF

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

Eligibility criteria: 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;

Primary outcomes:
measure: Stroke (Hemorrhagic, Ischemic)
timeFrame: From October 1, 2009 through July 31, 2013 (the study period)
measure: Major Bleeding
timeFrame: From October 1, 2009 through July 31, 2013 (the study period)
Secondary outcomes:
measure: Ischemic Stroke
timeFrame: From October 1, 2009 through July 31, 2013 (the study period)
measure: Hemorrhagic Stroke
timeFrame: From October 1, 2009 through July 31, 2013 (the study period).
measure: Major Intracranial Bleeding
timeFrame: From October 1, 2009 through July 31, 2013 (the study period).
measure: Major Extracranial Bleeding
timeFrame: From October 1, 2009 through July 31, 2013 (the study period).
measure: Major GI Bleeding
timeFrame: From October 1, 2009 through July 31, 2013 (the study period).
measure: Major Upper GI Bleeding
timeFrame: From October 1, 2009 through July 31, 2013 (the study period).
measure: Major Lower GI Bleeding
timeFrame: From October 1, 2009 through July 31, 2013 (the study period).
measure: Major Urogenital Bleeding
timeFrame: From October 1, 2009 through July 31, 2013 (the study period).
measure: Major Other Bleeding
timeFrame: From October 1, 2009 through July 31, 2013 (the study period).
measure: Transient Ischemic Attack
timeFrame: From October 1, 2009 through July 31, 2013 (the study period).
measure: Myocardial Infarction
timeFrame: From October 1, 2009 through July 31, 2013 (the study period).
measure: Venous Thromboembolism
timeFrame: From October 1, 2009 through July 31, 2013 (the study period).
measure: Deep Vein Thrombosis
timeFrame: From October 1, 2009 through July 31, 2013 (the study period).
measure: Pulmonary Embolism
timeFrame: From October 1, 2009 through July 31, 2013 (the study period).
measure: Death
timeFrame: From October 1, 2009 through July 31, 2013 (the study period).
Other outcomes:
Locations:
city: Lexington
country: United States
facility: 1160.183.01 Boehringer Ingelheim Investigational Site
state: Massachusetts
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: