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Personalized Evidence-based Medicine in Patients With Atrial Fibrillation

Personalized Evidence-based Medicine Improves Outcomes of Anticoagulation Therapy in Patients With Atrial Fibrillation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04774341
Enrollment
4200
Registered
2021-03-01
Start date
2021-01-10
Completion date
2021-02-24
Last updated
2021-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence to Personalized EBM Anticoagulant Treatment in Patients at High Risk for Stroke

Keywords

Atrial fibrillation, Personalized evidence-based medicine, Clinical decision support systems, Stroke, Anticoagulation, Guidelines

Brief summary

A retrospective analysis

Detailed description

4200 EMR of patients at high risk for stroke with 1-year follow-up will be enrolled in the current study and analyzed by clinical decision support systems (CDSS MedicBK) utilizing a core laboratory.

Interventions

DRUGanticoagulation treatment

Adherence to personalized evidence-based anticoagulant treatment in patients at high risk for stroke with atrial fibrillation

Sponsors

Center for New Medical Technologies, Novosibirsk, Russia
CollaboratorOTHER
I.M. Sechenov First Moscow State Medical University
CollaboratorOTHER
University of Rochester
CollaboratorOTHER
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
CollaboratorOTHER
Center of Personalized Medicine, Pirogova
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

EMR only if an ECG diagnosis (12-lead ECG, 24-h Holter, or other electrocardiographic documentation) confirming AF was made in patients at high risk for stroke by CHA2DS2-VASc (≥2 in men and ≥3 in women).

Exclusion criteria

No

Design outcomes

Primary

MeasureTime frameDescription
The percentage of guideline-based and personalized EBM recommendations1-yearThe percentage of guideline-based and personalized EBM recommendations acted on by clinicians for anticoagulant therapy in patients with AF. All discrepancies between routine and CDSS-recommended treatment resulting in frame of guideline-based therapy and personalized EBM therapy will be adjudicated by core laboratory.

Secondary

MeasureTime frameDescription
Quantify the performance of the CDSS (MedicBK) algorithm1-yearQuantify the performance of the CDSS (MedicBK) algorithm for presents treatment suggestions in frame of guideline-based therapy and personalized EBM therapy: the sensitivity, specificity, NPV, and PPV
1-year FU outcomes1-yearOutcomes for all-cause mortality, thromboembolism (TE), bleeding, and the composite endpoint of any thromboembolism, cardiovascular death, or bleeding in relation to whether they were guideline-based treatment or personalized EBM treatment. Thromboembolism refers to stroke, transient ischemic attack, acute coronary syndrome, coronary intervention, cardiac arrest, peripheral embolism, and pulmonary embolism
Predictors1-yearPredictors of guideline-based and personalized EBM adherence

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026