Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients

NCT02461602

Last updated date
Study Location
Foothill Cardiology
Pasadena, California, 91105, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrial Fibrillation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 18 years or older at the time of enrollment

- Electrocardiographically confirmed AF

- Able to complete patient-reported outcomes surveys

- Initiated warfarin therapy in the prior 3 months

- Ability to adhere to regular clinical visits

- Ability to sign informed consent

- Ability to read/comprehend/speak English

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Anticipated life expectancy less than six months (as determined by the site
investigator)


- Transient AF secondary to a reversible condition (hyperthyroidism, pulmonary embolism,
post-cardiothoracic surgery)


- Recent Deep Venous Thrombosis(DVT) or Pulmonary Embolism (PE) (within 6 months)


- Participation in a randomized trial of anticoagulation for AF


- Use of a home international normalized ratio (INR) monitoring system

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Atrial FibrillationIntegRAted Chronic Care Program at Specialized AF Clinic Versus Usual CarE in Patients With Atrial Fibrillation - RACE4
NCT01740037
  1. Groningen,
  2. Groningen,
  3. Haarlem,
  4. Leeuwarden,
  5. Maastricht,
  6. Nijmegen,
  7. Zaandam,
  8. Zwolle,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Atrial FibrillationEvaluation of Safety and Effectiveness on Oral Anticoagulants
NCT03765242
  1. Minato-ku, Tokyo
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Atrial FibrillationAmiodarone to Prevent Post-Operative Arrhythmias
NCT00251706
  1. Calgary, Alberta
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients
Official Title Eliminate Thromboembolism (ELITE): Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients
Brief Summary ELITE (Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients) is a two year research project to assess warfarin management issues faced by atrial fibrillation (AF) patients in ambulatory settings.
Detailed Description

ELITE will be a prospective, multicenter observational study of 500 participants to characterize demographics, comorbidities, risk profiles, socioeconomic status, and patient preferences related to anticoagulation management. The primary study endpoint will be warfarin discontinuation without resumption as documented in the medical record. Secondary outcomes of interest include warfarin adherence and factors associated with suboptimal adherence and/or permanent discontinuation. Clinical data, including demographics, medical history, and comorbidities, will be abstracted and entered by site coordinators. An internal survey developed by Duke Clinical Research Institute (DCRI) will be administered to patients during regularly scheduled clinic visits. Survey items will include patient treatment priorities, perceived risk of bleeding and/or stroke, barriers to adherence, and treatment satisfaction. Subjects will complete a survey at baseline and at the followup visit closest to 6 months after enrollment.

This study will provide the foundation for numerous potential future questions about medication adherence and barriers to treatment, such as a survey on physician preferences/ shared decision-making (concordance between physician and patient preferences), followup to capture clinical events, and interventions to improve long-term medication adherence in AF.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Atrial Fibrillation patients
Condition Atrial Fibrillation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 30, 2017)
251
Original Estimated Enrollment
 (submitted: June 2, 2015)
250
Actual Study Completion Date May 31, 2018
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 18 years or older at the time of enrollment
  • Electrocardiographically confirmed AF
  • Able to complete patient-reported outcomes surveys
  • Initiated warfarin therapy in the prior 3 months
  • Ability to adhere to regular clinical visits
  • Ability to sign informed consent
  • Ability to read/comprehend/speak English

Exclusion Criteria:

  • Anticipated life expectancy less than six months (as determined by the site investigator)
  • Transient AF secondary to a reversible condition (hyperthyroidism, pulmonary embolism, post-cardiothoracic surgery)
  • Recent Deep Venous Thrombosis(DVT) or Pulmonary Embolism (PE) (within 6 months)
  • Participation in a randomized trial of anticoagulation for AF
  • Use of a home international normalized ratio (INR) monitoring system
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02461602
Other Study ID Numbers Pro00061054
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Responsible Party Duke University
Study Sponsor Duke University
Collaborators
  • Bristol-Myers Squibb
  • Pfizer
Investigators
Principal Investigator:Emily O'Brien, PhDDCRI
PRS Account Duke University
Verification Date October 2018