Anticoagulant Utilization Pattern

Atrial Fibrillation Clinical Trial

Official title:

A Description of Warfarin and NOAC Utilization Patterns Including Initiation, Switching, and Discontinuation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847560
• Other study ID #: 1160.177
• Status: Completed
• Start date: April 17, 2013
• Est. completion date: November 1, 2017

Study information

• Verified date: March 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333664
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Treatment Persistence Over Time	Overall treatment persistence in UnitedHealth and MarketScan cohorts are presented as the percentage of patients who were persistent to treatment after 3, 6 and 12 months of follow-up for all time periods combined and matched cohort. Based on two US-based longitudinal healthcare claims databases (MarketScan and unitedHealth Research Database) the three separate study cohorts warfarin vs dabigatran, warfarin vs rivaroxaban and warfarin vs apixaban cohort were formed for each database.	From January 2009 to September 2015 (The study period)

External Links

•   Link