The Comparative Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-valvular Atrial Fibrillation Population With Humana Healthcare Coverage

NCT02061748 | Completed Results

• 1 other identifier: 1160.192
• Study Type: observational
• Target: 38,499
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (4)

• Stroke (Primary Analysis)

  This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the primary analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy. Hemorrhagic stroke includes: Subarachnoid hemorrhage (SAH) and Intracerebral hemorrhage (ICH) but excludes previous listed diagnoses if "traumatic brain injury" or "rehabilitation care" is present. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.

  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)

• Stroke (Post-hoc Analysis)

  This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.

  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)

• Major Bleeding (Primary Analysis)

  This outcome measure describes the incidence of major bleeding (hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the primary analysis. Major Intracranial Bleeding includes subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid hemorrhage following injury without mention of open intracranial wound, subdural hemorrhage following injury without mention of open intracranial wound, extradural hemorrhage following injury without mention of open intracranial wound, other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if major trauma was present. Major extracranial bleeding includes major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding. Either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization were used.

  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)

• Major Bleeding (Post-hoc Analysis)

  This outcome measure describes the incidence of major bleeding (Inclusive of hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.

  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 (30)

• Ischemic Stroke (Primary Analysis)

  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)

• Ischemic Stroke (Post-hoc Analysis)

  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)

• Hemorrhagic Stroke (Primary Analysis)

  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)

• Hemorrhagic Stroke (Post-hoc Analysis)

  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)

• Major Intracranial Bleeding (Primary Analysis)

  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)

Study Arms (2)

dabigatran

Drug: Observational

warfarin

Interventions

Observational DRUG

Retrospective Chart Review

dabigatran

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NVAF

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Comprehensive Health Insights, Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Limitations and Caveats

This was retrospective study using the Humana database. Adverse events (other than the primary and secondary endpoints) were not collected per protocol.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 13, 2014
• Study Start: October 28, 2014
• Primary Completion: March 15, 2016
• Study Completion: March 15, 2016
• Last Updated: June 8, 2017
• Results First Posted: June 8, 2017

Record last verified: 2017-06

Locations

US (1)