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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02043808
First received: January 10, 2014
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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


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 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 ]

Study Start Date: January 2014
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dabigatran
Warfarin

Detailed Description:

Study Design:

Retrospective

  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:

  • 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
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: NCT02043808

Locations
United States, Massachusetts
1160.183.01 Boehringer Ingelheim Investigational Site
Lexington, Massachusetts, 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: NCT02043808     History of Changes
Other Study ID Numbers: 1160.183
Study First Received: January 10, 2014
Last Updated: June 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Dabigatran
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014