Effectiveness of Oral Anticoagulants in Elderly Patients With Non-Valvular Atrial Fibrillation and Heart Failure

Heart Failure Clinical Trial

Official title:

Real-World Comparative Effectiveness Research Among Elderly Non-valvular Atrial Fibrillation (NVAF) Patients With Heart Failure (HF) Using Oral Anticoagulants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508271
• Other study ID #: CV185-681
• Status: Completed
• Start date: November 30, 2017
• Est. completion date: November 8, 2018

Study information

• Verified date: January 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational study of elderly individuals diagnosed with Non-Valvular Atrial Fibrillation and Heart Failure who are beginning oral blood thinners

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60000
• Est. completion date: November 8, 2018
• Est. primary completion date: November 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Were age greater than or equal to 65 years as of the index date

• Had greater than or equal to 1 diagnosis of AF prior to or on the index date

• Had greater than or equal to 1 diagnosis claim of HF during the 12 months prior to or on the index date

• Had 1 or more pharmacy claim for oral blood thinners

Exclusion Criteria:

• Claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date

• Pharmacy claim for warfarin, apixaban, dabigatran, edoxaban or rivaroxaban during the 12-month baseline period

• Greater than 1 oral anticoagulants prescription claim on the index date and/or with a follow-up less than 1 day

• Had medical claim indicating VTE in the 12 months prior to index date

Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
United States	Local Institution	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of stroke/systemic embolism (SE)		Approximately 195 weeks
Primary	Incidence of major bleeding		Approximately 195 weeks
Secondary	Incidence of miocardial infarction (MI)		Approximately 195 weeks
Secondary	Incidence of all cause mortality		Approximately 195 weeks
Secondary	Incidence of all cause hospitalization		Approximately 195 weeks
Secondary	Incidence of major adverse cardiac event		Approximately 195 weeks

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form