Adherence to Personalized EBM Anticoagulant Treatment in Patients at High Risk for StrokeNCT04774341
Personalized Evidence-based Medicine in Patients With Atrial Fibrillation
An observational study of Adherence to Personalized EBM Anticoagulant Treatment in Patients at High Risk for Stroke, run by Center of Personalized Medicine, Pirogova at 1 site in Russia.
Trial summary
A retrospective analysis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adherence to Personalized EBM Anticoagulant Treatment in Patients at High Risk for Stroke
- What is being tested?
- anticoagulation treatment
- How many people
- 4,200 participants
- Where
- 1 siteRussia
- Study dates
- 10 Jan 2021to 24 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients at high risk for stroke with atrial fibrillation
Who may be able to join
- 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).
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Evidence-based Medicine Improves Outcomes of Anticoagulation Therapy in Patients With Atrial Fibrillation
A retrospective analysis
Read the 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.
- Being tested
- anticoagulation treatment
- Keywords
- Atrial fibrillation, Personalized evidence-based medicine, Clinical decision support systems, Stroke, Anticoagulation, Guidelines
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anticoagulation treatmentDrug
Adherence to personalized evidence-based anticoagulant treatment in patients at high risk for stroke with atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| CDSS (MedicBK) Analysis | Not described Receives: Drug: anticoagulation treatment | |
| Core Laboratory Analysis | Not described Receives: Drug: anticoagulation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-year
Secondary outcomes (3)
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
Measured: 1-year
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
Measured: 1-year
Predictors
Predictors of guideline-based and personalized EBM adherence
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start10 Jan 2021
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence to Personalized EBM Anticoagulant Treatment in Patients at High Risk for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center of Personalized Medicine, Pirogova
- Sponsor type
- University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia, I.M. Sechenov First Moscow State Medical University, University of Rochester, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Responsible party
- Principal investigator, Evgeny Pookushalov, Center of Personalized Medicine, Pirogova
- Investigators
- Evgeny Pokushalov, Prof. MD PhD, Principal investigator, Center for New Medical Technologies, Novosibirsk, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774341
- Sponsor's protocol ID
- 20210225
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Evidence-based Medicine Improves Outcomes of Anticoagulation Therapy in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04774341
- Acronym / sponsor ID
- 20210225
- Keywords
- Atrial fibrillation, Personalized evidence-based medicine, Clinical decision support systems, Stroke, Anticoagulation, Guidelines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,200 participants (actual)
- Lead sponsor
- Center of Personalized Medicine, PirogovaUniversity, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia, I.M. Sechenov First Moscow State Medical University, University of Rochester, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDSS (MedicBK) Analysis | – | Drug: anticoagulation treatment |
| Core Laboratory Analysis | – | Drug: anticoagulation treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients at high risk for stroke with atrial fibrillation
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anticoagulation treatmentAdherence to personalized evidence-based anticoagulant treatment in patients at high risk for stroke with atrial fibrillation | Drug | CDSS (MedicBK) Analysis, Core Laboratory Analysis |
Primary outcome
The percentage of guideline-based and personalized EBM recommendations
Time frame: 1-year
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.
3 secondary outcomes
Quantify the performance of the CDSS (MedicBK) algorithm
Time frame: 1-year
1-year FU outcomes
Time frame: 1-year
Predictors
Time frame: 1-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evgeny Pokushalov, Prof. MD PhD principal investigator
Center for New Medical Technologies, Novosibirsk, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adherence to Personalized EBM Anticoagulant Treatment in Patients at High Risk for Stroke, run by Center of Personalized Medicine, Pirogova at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of guideline-based and personalized EBM recommendations (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.