Effectiveness of Oral Anticoagulants in Elderly Patients... | NCT03508271

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

NCT03508271

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jan 4, 2019Actual

Enrollment

60,000Actual

Phase

Not provided

Conditions

Atrial Fibrillation
Heart Failure

Interventions

Non-Interventional

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2017Actual

Primary Completion Date

Nov 8, 2018Actual

Completion Date

Nov 8, 2018Actual

First Submitted Date

Apr 16, 2018

First Submission Date that Met QC Criteria

Apr 16, 2018

First Posted Date

Apr 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2019

Last Update Posted Date

Jan 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elderly individuals with NVAF and HF who are taking OAC's			Other: Non-Interventional

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional	Other	Non-Interventional	Elderly individuals with NVAF and HF who are taking OAC's

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of stroke/systemic embolism (SE)		Approximately 195 weeks
Incidence of major bleeding		Approximately 195 weeks

Secondary Outcomes

Measure	Description	Time Frame
Incidence of miocardial infarction (MI)		Approximately 195 weeks
Incidence of all cause mortality		Approximately 195 weeks
Incidence of all cause hospitalization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

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)

Sampling Method

Probability Sample

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Ann Arbor	Michigan	48104	United States

Label	URL
BMS Clinical Trial Information	View source
Investigator Inquiry Form	View source
FDA Safety Alerts and Recalls

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D006333	Heart Failure

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided