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

NCT03508271 | Completed

• 1 other identifier: CV185-681
• Study Type: observational
• Target: 60,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation; Heart Failure

Outcome Measures

Primary Outcomes (2)

• Incidence of stroke/systemic embolism (SE)

  Approximately 195 weeks

• Incidence of major bleeding

  Approximately 195 weeks

Secondary Outcomes (4)

• Incidence of miocardial infarction (MI)

  Approximately 195 weeks

• Incidence of all cause mortality

  Approximately 195 weeks

• Incidence of all cause hospitalization

  Approximately 195 weeks

• Incidence of major adverse cardiac event

  Approximately 195 weeks

Study Arms (1)

Elderly individuals with NVAF and HF who are taking OAC's

Other: Non-Interventional

Interventions

Non-Interventional OTHER

Non-Interventional

Elderly individuals with NVAF and HF who are taking OAC's

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly individuals diagnosed with NVAF (non-valvular atrial fibrillation) and HF (heart failure) who are new initiators of DOAC's (direct oral anticoagulants)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Ann Arbor, Michigan, 48104, United States

Location

Related Links

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

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 25, 2018
• Study Start: November 30, 2017
• Primary Completion: November 8, 2018
• Study Completion: November 8, 2018
• Last Updated: January 4, 2019

Record last verified: 2019-01

Locations

US (1)