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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.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02061748
First received: February 12, 2014
Last updated: February 7, 2017
Last verified: February 2017

February 12, 2014
February 7, 2017
October 2014
March 2016   (Final data collection date for primary outcome measure)
  • Stroke [ Time Frame: up to 21 months ]
  • Bleeding [ Time Frame: up to 21 months ]
Same as current
Complete list of historical versions of study NCT02061748 on ClinicalTrials.gov Archive Site
  • Ischemic stroke [ Time Frame: up to 21 months ]
  • Hemorrhagic stroke [ Time Frame: up to 21 months ]
  • Major intracranial bleeding [ Time Frame: up to 21 months ]
  • Major extracranial bleeding [ Time Frame: up to 21 months ]
  • Major GI bleeding [ Time Frame: up to 21 months ]
  • Major upper GI bleeding [ Time Frame: up to 21 months ]
  • Major lower GI bleeding [ Time Frame: up to 21 months ]
  • Major urogenital bleeding [ Time Frame: up to 21 months ]
  • Major other bleeding [ Time Frame: up to 21 months ]
  • Transient Ischemic Attack [ Time Frame: up to 21 months ]
  • Myocardial Infarction [ Time Frame: up to 21 months ]
  • Venous Thromboembolism [ Time Frame: up to 21 months ]
  • Deep Vein Thrombosis [ Time Frame: up to 21 months ]
  • Pulmonary Embolism [ Time Frame: up to 21 months ]
  • Death [ Time Frame: up to 21 months ]
Same as current
Not Provided
Not Provided
 
The Comparative Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-valvular Atrial Fibrillation Population With Humana Healthcare Coverage
The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Humana Non-Valvular Atrial Fibrillation (NVAF) Patient Population-A Retrospective Database Analysis
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.

Study Design:

Observational
Observational Model: Other
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
NVAF
Atrial Fibrillation
Drug: Observational
Retrospective Chart Review
  • dabigatran
    Intervention: Drug: Observational
  • warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20000
March 2016
March 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02061748
1160.192
Not Provided
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP