Status:
COMPLETED
IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation
Lead Sponsor:
Harvard Pilgrim Health Care
Collaborating Sponsors:
Duke Clinical Research Institute
Clinical Trials Transformation Initiative
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
30+ years
Phase:
NA
Brief Summary
The purpose of this study is to use a decentralized claims database to determine whether education on stroke prevention in atrial fibrillation (AF) among AF patients and their providers can result in ...
Detailed Description
The study is a prospective, randomized, and open-label education intervention trial. Patients with AF and a CHA₂DS₂-VASc score of 2 or greater will be randomized in a 1:1 ratio to an intervention coho...
Eligibility Criteria
Inclusion
- Two or more diagnoses of AF (ICD-9 and/or 10 codes) at least one day apart and with at least one diagnosis within the last 12 months prior to the last date in the current approved data used for cohort identification
- CHA₂DS₂-VASc score of 2 or greater
- Medical and pharmacy insurance coverage of at least the prior year as identified via administrative claims databases of one of the participating data partners as of the date of randomization
- Age 30 years or greater as of the last date in the current approved data used for cohort identification
Exclusion
- Evidence of OAC medication fill during the 12 months prior to randomization (determined at randomization for the early intervention cohort and 12 months post-randomization for the delayed intervention cohort)
- Conditions other than AF that require anticoagulation, including treatment of deep venous thrombosis, pulmonary embolism, or ever having had a mechanical prosthetic heart valve prior to the last date in the current approved data used for cohort identification
- Pregnancy within 6 months of the last date in the current approved data used for cohort identification
- Any known history of intracranial hemorrhage prior to the last date in the current approved data used for cohort identification
- Hospitalization for bleeding within the last 6 months of the last date in the current approved data used for cohort identification
- Patients with recent P2Y12 antagonist use (i.e. clopidogrel, prasugrel, ticlopidine, or ticagrelor within 90 days of the last date in the current approved data used for cohort identification
Key Trial Info
Start Date :
September 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
64666 Patients enrolled
Trial Details
Trial ID
NCT03259373
Start Date
September 25 2017
End Date
December 31 2021
Last Update
April 9 2025
Active Locations (4)
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1
Humana Healthcare Research, Inc.
Louisville, Kentucky, United States, 40202
2
Harvard Pilgrim Health Care
Quincy, Massachusetts, United States, 02169
3
OptumInsight, Inc
Waltham, Massachusetts, United States, 02451
4
Aetna, Inc.
Blue Bell, Pennsylvania, United States, 19422