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: July 1, 2015
Last verified: July 2015
  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 (Hemorrhagic, Ischemic) [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period) ] [ Designated as safety issue: No ]

    Event rate of stroke (hemorrhagic, ischemic).

    Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.


  • Major Bleeding [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period) ] [ Designated as safety issue: Yes ]

    Event rate of major bleeding.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.



Secondary Outcome Measures:
  • Ischemic Stroke [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period) ] [ Designated as safety issue: No ]

    Event rate of ischemic stroke.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.


  • Hemorrhagic Stroke [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period). ] [ Designated as safety issue: Yes ]

    Event rate of hemorrhagic stroke.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.


  • Major Intracranial Bleeding [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period). ] [ Designated as safety issue: Yes ]

    Event rate of major intracranial bleeding.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.


  • Major Extracranial Bleeding [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period). ] [ Designated as safety issue: Yes ]

    Event rate of major extracranial bleeding.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.


  • Major GI Bleeding [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period). ] [ Designated as safety issue: Yes ]

    Event rate of major gastrointestinal (GI) bleeding.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.


  • Major Upper GI Bleeding [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period). ] [ Designated as safety issue: Yes ]

    Event rate of major upper gastrointestinal (GI) bleeding.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.


  • Major Lower GI Bleeding [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period). ] [ Designated as safety issue: Yes ]

    Event rate of major lower gastrointestinal (GI) bleeding.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.


  • Major Urogenital Bleeding [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period). ] [ Designated as safety issue: Yes ]

    Event rate of major urogenital bleeding.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.


  • Major Other Bleeding [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period). ] [ Designated as safety issue: Yes ]

    Event rate of major other bleeding.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.


  • Transient Ischemic Attack [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period). ] [ Designated as safety issue: No ]

    Event rate of transient ischemic attacks.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.


  • Myocardial Infarction [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period). ] [ Designated as safety issue: No ]

    Event rate of myocardial infarction.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.


  • Venous Thromboembolism [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period). ] [ Designated as safety issue: No ]

    Event rate of venous thromboembolism.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.


  • Deep Vein Thrombosis [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period). ] [ Designated as safety issue: No ]

    Event rate of deep vein thrombosis.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.


  • Pulmonary Embolism [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period). ] [ Designated as safety issue: No ]

    Event rate of pulmonary embolism.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.


  • Death [ Time Frame: From October 1, 2009 through July 31, 2013 (the study period). ] [ Designated as safety issue: No ]

    Event rate of death, due to any cause.

    The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.



Enrollment: 25586
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
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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

Additional 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
Results First Received: May 22, 2015
Last Updated: July 1, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 26, 2015