Adherence of Apixaban and Warfarin in Patients With Arterial Fibrillation in Real-world Setting in Sweden

Anticoagulation Clinical Trial

Official title:

Adherence of Apixaban and Warfarin in Patients With Atrial Fibrillation in Real-world Setting in Sweden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492828
• Other study ID #: CV185-323
• Status: Completed
• Phase: N/A
• First received: June 30, 2015
• Last updated: May 17, 2016
• Start date: June 2014
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Observational

Clinical Trial Summary

This will be a retrospective cohort study using national register linkage data (including prescription, inpatient, mortality, and socioeconomic data). The study period will be from May 29, 2013 to June 30, 2015. Patients will be followed from the start of treatment (index date) until their death, exiting the database, or until the end of the study period (June 30, 2015).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41000
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• For the AF cohort

• Patients that have =1 AF diagnosis registered in the patient register

• Apixaban subcohort 1

• Patients eligible for the AF cohort

• Patients that had a first prescription for apixaban during the identification period without previous prescriptions for NOACs or warfarin during the preceding 12 months

• Warfarin subcohort 1

• Patients eligible for the AF cohort

• Patients that had a first prescription for warfarin during the identification period without previous prescriptions for NOACs or warfarin during the preceding 12 months

• Apixaban subcohort 2

• Patients eligible for the AF cohort

• Patients that had a first prescription for apixaban during

Exclusion Criteria:

• For the AF cohort:

• Patients with valvular AF will be excluded (see definition Appendix 1)

• Warfarin subcohort 1:

• Patients will be excluded from this sub-cohort if they had at least one prescription for warfarin or NOACs during the 12-month period preceding the first prescription for warfarin during the identification period, ie, the index date

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anticoagulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare adherence among Atrial Fibrillation (AF) patients initiating treatment with apixaban (without previous warfarin or novel anticoagulant (NOAC) use) compared with those initiating treatment with warfarin (without previous warfarin or NOAC use)	Adherence: Adherence will be defined including missing doses and treatment discontinuation using the following approaches: "Drug at disposal" approach: Based on information on prescribed dosing (mg/day) and information on filled prescriptions (mg expensed from the pharmacy); it is possible to calculate for how long a period the drug will last for that specific patient. Adherence is then defined using the Medication Possession Ratio (MPR) calculated as the ratio of number of days of treatment supply divided by the total length of follow-up time, and converted to a percentage (in the graph below illustrated as the sum of the grey horizontal bars divided by the length of follow-up, ie, time between index date and end of follow-up). The MPR will be computed as a continuous and binary variable (MPR>80%, ie, high vs low adherence)	approximately 6 to 12 months	No
Primary	Compare persistence among AF patients initiating treatment with apixaban (without previous warfarin or NOAC use) compared with those initiating treatment with warfarin (without previous warfarin or NOAC use)	Persistence: Persistence will be defined as treatment discontinuation and will be measured by estimating the following: Time to discontinuation: Date of therapy cessation is not possible to determine with certainty due to the nature of registry data. In order to be able to estimate the time of discontinuation, patients will be considered on treatment for the full time between two purchases as long as they have at least one refill in a six month period. If there is no new purchase within six months the patient is considered to have terminated treatment at a date corresponding to how long the last prescription will last (in the graph below illustrated as the time between index date and the end of the "last" horizontal bar).; Cumulative incidence of persistent patients still on index treatment at the every 3- month interval after index date (treatment initiation)	approximately 6 to 12 months	No
Secondary	Describe and compare patient characteristics (demographics) among AF patients through questionnaire	Describe and compare patient characteristics (eg, demographics and clinical) among AF patients who: Initiate apixaban without previous anticoagulant treatment (warfarin or NOAC use); Initiate apixaban with previous war; Demographic parameters : Age-groups, Sex, Socioeconomic variables (e.g. education, disposable income)	approximately 6 to 12 months	No
Secondary	Describe and compare patient characteristics (clinical) among AF patients through questionnaire	Describe and compare patient characteristics (eg, demographics and clinical) among AF patients who: Initiate apixaban without previous anticoagulant treatment (warfarin or NOAC use); Initiate apixaban with previous war; Clinical Characteristics: History of stroke/TIA/systemic, embolism, Diabetes, Hypertension, Heart failure, Vascular disease, Intracranial bleeding, Any bleeding, Kidney disease, Liver disease, Dementia, Valvular AF, Ischemic stroke, Unspecified stroke, TIA, Systemic embolism, Coronary disease, End Stage Renal Disease	approximately 6 to 12 months	No

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