NCT04774341

Brief Summary

A retrospective analysis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

February 24, 2021

Last Update Submit

February 26, 2021

Conditions

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

Keywords

Atrial fibrillationPersonalized evidence-based medicineClinical decision support systemsStrokeAnticoagulationGuidelines

Outcome Measures

Primary Outcomes (1)

  • The percentage of guideline-based and personalized EBM recommendations

    The 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.

    1-year

Secondary Outcomes (3)

  • Quantify the performance of the CDSS (MedicBK) algorithm

    1-year

  • 1-year FU outcomes

    1-year

  • Predictors

    1-year

Study Arms (2)

CDSS (MedicBK) Analysis

Drug: anticoagulation treatment

Core Laboratory Analysis

Drug: anticoagulation treatment

Interventions

anticoagulation treatmentDRUG

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

CDSS (MedicBK) AnalysisCore Laboratory Analysis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients at high risk for stroke with atrial fibrillation

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evgeny Pokushalov

Novosibirsk, 630090, Russia

Location

MeSH Terms

Conditions

Atrial FibrillationStroke

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Evgeny Pokushalov, Prof. MD PhD

    Center for New Medical Technologies, Novosibirsk, Russia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director for research and development

Study Record Dates

First Submitted

February 24, 2021

First Posted

March 1, 2021

Study Start

January 10, 2021

Primary Completion

February 24, 2021

Study Completion

February 24, 2021

Last Updated

March 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)