Anticoagulant Utilization Pattern

NCT01847560 | Completed Results

• 1 other identifier: 1160.177
• Study Type: observational
• Target: 333,664
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to describe utilization patterns for oral anticoagulants over time in patients with non-valvular atrial fibrillation at risk for stroke using electronic claims data from a United States commercial insurance database.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (5)

• Description of the Characteristics of Anticoagulant Initiators

  The analyses described the characteristics of patients treated with various oral anticoagulants. CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (\>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above).

  From January 2009 to September 2015 (The study period)

• Percentage of Patients Initiating Specific Anticoagulant

  Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. This is related to UnitedHealth database and no treatment initiation rate was estimated in MarketScan as the study cohort was defined from a population of oral anticoagulants users. The overall number of participants analyzed "609201" reported for each of the treatment arm below corresponds to overall patients numbers in UnitedHealth for the entire study period rather than for each of the treatment arm. Likewise the number of participants for each of the treatment arm for different time period corresponds to the total number of participants for the specific study period rather than for each of the treatment arm. Incident users at given time period could also be counted in later time period if the patient discontinued the drug and had re-entry during the study period.

  From January 2009 to September 2015 (The study period)

• Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran

  Percentage of patients initiating specific anticoagulant dose of dabigatran across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.

  From January 2009 to September 2015 (The study period)

• Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban

  Percentage of patients initiating specific anticoagulant dose of apixaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.

  From January 2009 to September 2015 (The study period)

• Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban

  Percentage of patients initiating specific anticoagulant dose of rivaroxaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.

  From January 2009 to September 2015 (The study period)

Secondary Outcomes (1)

• Treatment Persistence Over Time

  From January 2009 to September 2015 (The study period)

Study Arms (2)

Dabigatran

Warfarin or other New Oral Anticoagulant (NOAC)

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

Patients 18 years of age and older with non-valvular AF at risk for stroke treated with oral anticoagulation

You may qualify if:

• A recorded diagnosis of atrial fibrillation
• Initiation of oral anticoagulant medication
• Congestive Heart Failure, Hypertension, Age \> 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) Score \>=1
• At least 18 years of age on the date of anticoagulant initiation

You may not qualify if:

• Patients with missing or ambiguous age or sex information
• Patients with documented evidence of valvular disease
• Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the first dispensing
• Patients with prior use of any oral anticoagulant

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, 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 Centre
• 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
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: May 7, 2013
• Study Start: April 17, 2013
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: June 27, 2019
• Results First Posted: June 27, 2019

Record last verified: 2019-03

Locations

US (1)