Oral Anticoagulant Discontinuation, Adherence Patterns, Hospitalizations and Costs in Non-Valvular Atrial Fibrillation (NVAF) Patients

Atrial Fibrillation Clinical Trial

Official title:

Oral Anticoagulant Bleeding Rate and Discontinuation and Adherence Patterns in Non-Valvular Atrial Fibrillation (NVAF) Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792335
• Other study ID #: CV185-412
• Status: Completed
• Phase: N/A
• First received: June 2, 2016
• Last updated: June 6, 2016
• Start date: January 2012
• Est. completion date: August 2014

Study information

• Verified date: June 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

To describe the rate of discontinuation among Non-Valvular Atrial Fibrillation (NVAF) patients who were on warfarin and have switched to the Novel oral anticoagulants(NOACs).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28000
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals with NVAF who were on warfarin and have switched to the NOACs (dabigatran, rivaroxaban and apixaban) within the study period January 01, 2013 through March 31, 2014

• Individuals =18 years old on the index date

• At least 1 year of baseline period with history of continuous warfarin use in the baseline period for at least 3 months immediately before the index date

• At least 1 diagnosis of AF in the 12 months prior to index date

• Continuous eligibility with medical and pharmacy benefits for at least 12 months before the index date through 1 month after the index date

Exclusion Criteria:

• Individuals with a diagnosis of valvular heart disease or cardiac surgery during the 12 months prior to index date

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• apixaban

• dabigatran

• rivaroxaban

• warfarin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discontinuation rate of patients with prior warfarin use		up to 31 months	Yes
Primary	Rate of major bleeding events of patients with prior warfarin use		up to 31 months	Yes
Primary	Rate of hospitalization due to major bleeding events of patients with warfarin use		up to 31 months	Yes
Primary	Discontinuation rate of patients who were naïve to oral anticoagulant		up to 31 months	Yes
Primary	Rate of major bleeding events of patients who were naïve to oral anticoagulant		up to 31 months	Yes
Primary	Rate of hospitalization due to major bleeding events of patients who were naïve to oral anticoagulant		up to 31 months	Yes
Secondary	Rate of All-Cause Hospitalization		up to 31 months	Yes
Secondary	Rate of Atrial Fibrillation(AF)-Related Hospitalization		up to 31 months	Yes
Secondary	Rate of All-Cause Any Rehospitalization		up to 31 months	Yes
Secondary	Rate of AF-Related Any Rehospitalization		up to 31 months	Yes
Secondary	Rate of All-Cause Early Hospitalization		up to 31 months	Yes
Secondary	Rate of AF-Related Early Hospitalization		up to 31 months	Yes
Secondary	All-Cause Healthcare per patient per month (PPPM) cost		up to 31 months	Yes
Secondary	AF-related Healthcare per patient per month (PPPM) cost		up to 31 months	Yes

External Links

•   BMS Clinical Trial Information
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