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Completed

NCT Number: NCT02043808

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

1160.183.01 Boehringer Ingelheim Investigational Site

Lexington, Massachusetts, United States

About this study

Study Design:

Retrospective

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. Stroke (Hemorrhagic, Ischemic)

    Time frame: From October 1, 2009 through July 31, 2013 (the study period)

    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.

  2. Major Bleeding

    Time frame: From October 1, 2009 through July 31, 2013 (the study period)

    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 outcomes

  1. Ischemic Stroke

    Time frame: From October 1, 2009 through July 31, 2013 (the study period)

    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.

  2. Hemorrhagic Stroke

    Time frame: From October 1, 2009 through July 31, 2013 (the study period).

    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.

  3. Major Intracranial Bleeding

    Time frame: From October 1, 2009 through July 31, 2013 (the study period).

    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.

  4. Major Extracranial Bleeding

    Time frame: From October 1, 2009 through July 31, 2013 (the study period).

    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.

  5. Major GI Bleeding

    Time frame: From October 1, 2009 through July 31, 2013 (the study period).

    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.

  6. Major Upper GI Bleeding

    Time frame: From October 1, 2009 through July 31, 2013 (the study period).

    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.

  7. Major Lower GI Bleeding

    Time frame: From October 1, 2009 through July 31, 2013 (the study period).

    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.

  8. Major Urogenital Bleeding

    Time frame: From October 1, 2009 through July 31, 2013 (the study period).

    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.

  9. Major Other Bleeding

    Time frame: From October 1, 2009 through July 31, 2013 (the study period).

    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.

  10. Transient Ischemic Attack

    Time frame: From October 1, 2009 through July 31, 2013 (the study period).

    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.

  11. Myocardial Infarction

    Time frame: From October 1, 2009 through July 31, 2013 (the study period).

    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.

  12. Venous Thromboembolism

    Time frame: From October 1, 2009 through July 31, 2013 (the study period).

    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.

  13. Deep Vein Thrombosis

    Time frame: From October 1, 2009 through July 31, 2013 (the study period).

    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.

  14. Pulmonary Embolism

    Time frame: From October 1, 2009 through July 31, 2013 (the study period).

    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.

  15. Death

    Time frame: From October 1, 2009 through July 31, 2013 (the study period).

    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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2014
Registry last updated
Jul 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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