N/A
Completed N=64,666
IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation
Source: ClinicalTrials.gov NCT03259373 ↗Enrolled (actual)
64,666
Serious AEs
3.2%
Results posted
Apr 2025
Primary outcomePrimary: Proportion of Patients With Evidence of at Least One OAC Dispensing (Prescription Fill) (Defined as One OAC Dispensing or 4 INR (International Normalized Ratio) Tests) — 2,328; 2,330; 1403; 1362 Participants — p=0.79
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 increased use of oral anticoagulants (OAC) for stroke prevention among those AF patients with guideline-based indications for oral anticoagulation (CHA₂DS₂-VASc score of 2 or greater). Specifically, the investigators will conduct a prospective, randomized, open-label education intervention trial to evaluate the effect of the early patient and provider education interventions on the proportion of patients with evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4 international normalized ratio [INR tests] over the course of the follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time). A total of approximately 80,000 patients will be enrolled within multiple major health plans across the United States. The randomization will be performed by the central coordinating center, and the health plans will mail the educational intervention materials to their members and providers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Evidence of at Least One OAC Dispensing (Prescription Fill) (Defined as One OAC Dispensing or 4 INR (International Normalized Ratio) Tests) |
2,328; 2,330; 1403; 1362; 769; 738 | 0.79 |
| SECONDARY Rates of Hospitalization for Ischemic or Unknown Stroke |
341; 375 | 0.300 |
| SECONDARY Rates of Hospitalization for Hemorrhagic Stroke |
81; 64 | 0.122 |
| SECONDARY Rates of Hospitalization for Ischemic or Hemorrhagic Stroke |
419; 436 | 0.760 |
| SECONDARY Rates of Hospitalization for Ischemic or Hemorrhagic Stroke or Systemic Embolism |
441; 453 | 0.760 |
| SECONDARY Rates of Hospitalization for Ischemic or Hemorrhagic Stroke or Systemic Embolism or Bleeding |
733; 760 | 0.616 |
| SECONDARY Rates of Hospitalization for Bleeding |
382; 385 | 0.992 |
| SECONDARY Proportion of Patients Dispensed an OAC Within One Year |
9.84; 9.74 | 0.808 |
| SECONDARY Number of Days Covered by OAC Dispensing |
166.48; 168.15 | 0.853 |
| SECONDARY Proportion of Patients on Oral Anticoagulation |
1,135; 1,183 | 0.303 |
| SECONDARY All-cause In-hospital Mortality Rates |
492; 482 | 0.649 |
| SECONDARY Health Care Utilization for AF Patients |
40.40; 40.51; 38.17; 38.27; 0.66; 0.69 | 0.587 |
| SECONDARY Health Care Utilization for AF Patients, Days |
32.36; 32.76; 3.01; 3.10 | 0.279 |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03259373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.