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

NCT02043808 | Completed Results

• 1 other identifier: 1160.183
• Study Type: observational
• Target: 25,586
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Stroke (Hemorrhagic, Ischemic)

  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.

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

• Major Bleeding

  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.

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

Secondary Outcomes (15)

• Ischemic Stroke

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

• Hemorrhagic Stroke

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

• Major Intracranial Bleeding

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

• Major Extracranial Bleeding

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

• Major GI Bleeding

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

Study Arms (2)

Dabigatran

Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NVAF

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1160.183.01 Boehringer Ingelheim Investigational Site

Lexington, Massachusetts, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 23, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 3, 2015
• Results First Posted: July 3, 2015

Record last verified: 2015-07

Locations

US (1)