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

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: February 12, 2014
Last updated: July 11, 2016
Last verified: July 2016
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.

Condition Intervention
Atrial Fibrillation
Drug: Observational

Study Type: Observational
Study Design: Time Perspective: Retrospective
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

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Stroke [ Time Frame: up to 21 months ] [ Designated as safety issue: No ]
  • Bleeding [ Time Frame: up to 21 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ischemic stroke [ Time Frame: up to 21 months ] [ Designated as safety issue: No ]
  • Hemorrhagic stroke [ Time Frame: up to 21 months ] [ Designated as safety issue: No ]
  • Major intracranial bleeding [ Time Frame: up to 21 months ] [ Designated as safety issue: Yes ]
  • Major extracranial bleeding [ Time Frame: up to 21 months ] [ Designated as safety issue: Yes ]
  • Major GI bleeding [ Time Frame: up to 21 months ] [ Designated as safety issue: Yes ]
  • Major upper GI bleeding [ Time Frame: up to 21 months ] [ Designated as safety issue: Yes ]
  • Major lower GI bleeding [ Time Frame: up to 21 months ] [ Designated as safety issue: Yes ]
  • Major urogenital bleeding [ Time Frame: up to 21 months ] [ Designated as safety issue: Yes ]
  • Major other bleeding [ Time Frame: up to 21 months ] [ Designated as safety issue: Yes ]
  • Transient Ischemic Attack [ Time Frame: up to 21 months ] [ Designated as safety issue: No ]
  • Myocardial Infarction [ Time Frame: up to 21 months ] [ Designated as safety issue: No ]
  • Venous Thromboembolism [ Time Frame: up to 21 months ] [ Designated as safety issue: No ]
  • Deep Vein Thrombosis [ Time Frame: up to 21 months ] [ Designated as safety issue: No ]
  • Pulmonary Embolism [ Time Frame: up to 21 months ] [ Designated as safety issue: No ]
  • Death [ Time Frame: up to 21 months ] [ Designated as safety issue: No ]

Enrollment: 20000
Study Start Date: October 2014
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
dabigatran Drug: Observational
Retrospective Chart Review

Detailed Description:

Study Design:


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02061748

United States, Kentucky
1160.192.01 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim Identifier: NCT02061748     History of Changes
Other Study ID Numbers: 1160.192 
Study First Received: February 12, 2014
Last Updated: July 11, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on December 02, 2016