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
NCT number | NCT04774341 |
Other study ID # | 20210225 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 10, 2021 |
Est. completion date | February 24, 2021 |
Verified date | February 2021 |
Source | Center of Personalized Medicine, Pirogova |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A retrospective analysis
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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Evgeny Pokushalov | Novosibirsk |
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 |
Russian Federation,
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 |