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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02061748
First received: February 12, 2014
Last updated: August 7, 2014
Last verified: August 2014

February 12, 2014
August 7, 2014
August 2014
November 2014   (final data collection date for primary outcome measure)
  • Stroke [ Time Frame: up to 21 months ] [ Designated as safety issue: No ]
  • Bleeding [ Time Frame: up to 21 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT02061748 on ClinicalTrials.gov Archive Site
  • 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 ]
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:

n/a

Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

NVAF

Atrial Fibrillation
Not Provided
  • dabigatran
  • warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20000
November 2014
November 2014   (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.
Both
18 Years and older
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
United States
 
NCT02061748
1160.192
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
August 2014

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