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 July 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02061748
First received: February 12, 2014
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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
Atrial Fibrillation

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 ]

Estimated Enrollment: 20000
Study Start Date: July 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
dabigatran
warfarin

Detailed Description:

Study Design:

n/a

  Eligibility

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

NVAF

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.
  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 ClinicalTrials.gov identifier: NCT02061748

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
United States, Kentucky
1160.192.01 Boehringer Ingelheim Investigational Site Not yet recruiting
Louisville, Kentucky, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02061748     History of Changes
Other Study ID Numbers: 1160.192
Study First Received: February 12, 2014
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014