Personalized Evidence-based Medicine in Patients With Atrial Fibrillation

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04774341
• Other study ID #: 20210225
• Status: Completed
• Start date: January 10, 2021
• Est. completion date: February 24, 2021

Study information

• Verified date: February 2021
• Source: Center of Personalized Medicine, Pirogova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective analysis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4200
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Evgeny Pokushalov	Novosibirsk

Sponsors (5)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quantify the performance of the CDSS (MedicBK) algorithm	Quantify 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
Secondary	1-year FU outcomes	Outcomes 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	1-year
Secondary	Predictors	Predictors of guideline-based and personalized EBM adherence	1-year