Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients (ELITE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02461602|
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : April 9, 2019
|Condition or disease|
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]|
|Actual Enrollment :||251 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Eliminate Thromboembolism (ELITE): Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||May 31, 2018|
|Actual Study Completion Date :||May 31, 2018|
- Reason(s) for Warfarin discontinuation [ Time Frame: 6 months ]
- Change in Warfarin adherence [ Time Frame: Baseline and 6 months ]
- Frequency of hospitalizations [ Time Frame: Baseline and 6 months ]
- Frequency of bleeding events [ Time Frame: Baseline and 6 months ]
- Change in INR values [ Time Frame: Baseline and 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461602
|Principal Investigator:||Emily O'Brien, PhD||DCRI|