The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage

This study is currently recruiting participants.
Verified April 2014 by Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: January 10, 2014
Last updated: April 2, 2014
Last verified: April 2014

The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.

Atrial Fibrillation

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Department of Defense (DoD) 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:
  • Major lower GI bleeding [ Time Frame: up to 21 months ] [ Designated as safety issue: Yes ]
  • Ischemic stroke [ Time Frame: up to 21 months ] [ Designated as safety issue: No ]
  • 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 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: 17000
Study Start Date: January 2014
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Detailed Description:

Study Design:



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



Inclusion criteria:

  • Patients must be continuously enrolled in a health plan during the pre-index period;
  • Patients must have at least one inpatient, or one physician office visit, emergency room visit with a diagnosis of AF (ICD-9-CM diagnosis code: 427.31in any position) on the index date or during the pre-index period;
  • Patients must have a prescription for dabigatran or warfarin (this first prescription will be the index date);
  • Patients must be treatment naive from all OAC use prior to first dabigatran or warfarin prescription;
  • Aged 18-89 on the index date;

Exclusion criteria:

  • Patients with valvular procedures related to the baseline AF diagnosis will be excluded;
  • Patients with transient causes of AF such as hyperthyroidism, any cardiac surgery, pericarditis, mycoarditis, pulmonary embolism within 3 months prior to their first diagnosis of AF;
  Contacts and Locations
Please refer to this study by its identifier: NCT02043808

Contact: Boehringer Ingelheim Call Center 1-800-243-0127

United States, Massachusetts
1160.183.01 Boehringer Ingelheim Investigational Site Recruiting
Lexington, Massachusetts, United States
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Identifier: NCT02043808     History of Changes
Other Study ID Numbers: 1160.183
Study First Received: January 10, 2014
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014