The Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis

NCT03026556 | Completed Results FDA Drug

• 1 other identifier: 1160-0274
• Study Type: observational
• Target: 42,534
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and effectiveness of newly initiated dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in comparison to newly initiated rivaroxaban users and newly initiated apixaban users

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Stroke Overall (Hemorrhagic, Ischemic, Uncertain)

  The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest: 1. The day of discontinuation of the index NOAC exposure; 2. The day before a switch to an anticoagulant different from the index exposure; 3. The day before a change in dose for the index NOAC; 4. The end of continuous eligibility of a patient in the health plan (disenrollment); 5. The end of the study observation period; or 6. The date of death of the patient.

  Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

• Overall Major Bleeding

  The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.

  Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

Secondary Outcomes (11)

• Ischemic Stroke

  Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

• Hemorrhagic Stroke

  Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

• Major Intracranial Bleeding

  Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

• Major Extracranial Bleeding

  Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

• Major GI Bleeding

  Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

Study Arms (2)

Dabigatran vs. Rivaroxaban

OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, rivaroxaban (new oral anticoagulant or NOAC).

Drug: Dabigatran vs. Rivaroxaban

Dabigatran vs. Apixaban

OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, or apixaban (new oral anticoagulant or NOAC).

Drug: Dabigatran vs. Apixaban

Interventions

Dabigatran vs. Rivaroxaban DRUG

observed for 6 years

Dabigatran vs. Rivaroxaban

Dabigatran vs. Apixaban DRUG

Observed for 6 years

Dabigatran vs. Apixaban

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 patients, ≥18 years of age, enrolled within the DoD Military Health System, who have newly initiated dabigatran, rivaroxaban, or apixaban. Patients must be treatment naïve from OAC use prior to first (index) NOAC.

You may qualify if:

• Age 18+ on index date
• Patients must have been prescribed either dabigatran, rivaroxaban, or apixaban identified by pharmacy claim during the study period. The first dispensing date of either study drug will be defined as the index date;
• Patients must be treatment naïve from all OAC use prior to the first NOAC prescription, during study period.
• Patients must have at least 12 months of continuous eligibility prior to the index date;
• Patients must have at least one diagnosis code of atrial fibrillation, defined as International Classification of Diseases (ICD)-9-CM diagnosis of 427.31 or ICD-10-CM diagnosis of I48.0, I48.1, I48.2, I48.91 on the index date or during the pre-index period.

You may not qualify if:

• Less than 12 months of continuous eligibility in the pre-index period Any claim for OAC drug (oral use only) in the pre-index period Diagnosis of hyperthyroidism during the pre-index period
• Having at least one claim for alternative indications; orthopedic procedures, Venous thromboembolism (VTE) (includes deep vein thrombosis (DVT ) \& PE)) and the index NOAC prescription at the same time, or, the alternative indication for anticoagulant occurring within 3 months prior to index date in pre-period Having at least one claim with any of the following diagnoses or procedure codes in order to exclude patients with "transient" causes of Afib (3 months prior to index date in pre-period):
• Cardiac surgery
• Pericarditis
• Myocarditis Having at least one medical claim with any of the following diagnoses or procedures codes in order to exclude patients with "valvular" Afib (pre-period):
• Mitral stenosis
• Mitral stenosis with insufficiency
• Mitral valve stenosis and aortic valve stenosis
• Mitral valve stenosis and aortic valve insufficiency
• Diseases of other endocardial structures
• Other and unspecified rheumatic heart diseases
• Open heart valvuloplasty without replacement
• Open and other replacement of unspecified heart valve
• Open and other replacement of aortic valve
• Open and other replacement of mitral valve

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Health ResearchTx, LLC (HRTX): collaborator
• inVentiv Health Clinical (iVH): collaborator
• United States Department of Defense (DOD): collaborator

Study Sites (1)

Inventiv Health

Princeton, New Jersey, 08450, 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

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 20, 2017
• Study Start: December 29, 2016
• Primary Completion: August 23, 2017
• Study Completion: August 23, 2017
• Last Updated: June 3, 2019
• Results First Posted: June 3, 2019

Record last verified: 2019-02

Locations

US (1)