Clinical trial NCT02061748: The Comparative Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-valvular Atrial Fibrillation Population With Humana Healthcare Coverage
Official title: The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Humana 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: 2014-02-13
Enrollment: 38499
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NVAF

Brief summary: This study is an opportunity for Boehringer Ingelheim to collaborate with Humana to conduct comparative safety and effectiveness studies of dabigatran and warfarin using real world data from Humana's health plan operations.

Detailed description: Study Design:

n/a

Eligibility criteria: Inclusion criteria:

* Patient must have at least one inpatient, one physician office visit, or one emergency room visit with a diagnosis of AF on the index date or during the pre-index period.
* Patients must be continuously enrolled in a health plan during the pre-index period
* Patient must have a prescription for dabigatran or warfarin
* Patient must be treatment naive from all oral anticoagulant (OAC) use prior to first OAC prescription
* Aged 18-89 years on the index date. The index date is defined as the date of the first OAC prescription

Exclusion criteria:

* Diagnosis of hyperthyroidism during the pre-index period,
* Having claims for any of the following within 3 months prior to the first diagnosis of AF: cardiac surgery, pericarditis, myocarditis, pulmonary embolism.
* Any patients with at least one medical claim for valvular heart disease.

Primary outcomes:
measure: Stroke (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Stroke (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Major Bleeding (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Major Bleeding (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Secondary outcomes:
measure: Ischemic Stroke (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Ischemic Stroke (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Hemorrhagic Stroke (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Hemorrhagic Stroke (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Major Intracranial Bleeding (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Major Intracranial Bleeding (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Major Extracranial Bleeding (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Major Extracranial Bleeding (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Major GI Bleeding (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Major GI Bleeding (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Major Upper GI Bleeding (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Major Upper GI Bleeding (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Major Lower GI Bleeding (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Major Lower GI Bleeding (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Major Urogenital Bleeding (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Major Urogenital Bleeding (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Other Major Bleeds (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Other Major Bleeds (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Transient Ischemic Attack (TIA) (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: TIA (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Myocardial Infarction (MI) (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: MI (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Venous Thromboembolism (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Venous Thromboembolism (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Deep Vein Thrombosis (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Deep Vein Thrombosis (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Pulmonary Embolism (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: Pulmonary Embolism (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: All-cause Death (Primary Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
measure: All-cause Death (Post-hoc Analysis)
timeFrame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Comprehensive Health Insights, Louisville
state: Kentucky
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: