AnticoagulantsNCT05319340
I.M. Sechenov First Moscow State Medical University (Sechenov University)
A study testing prescribing anticoagulant therapy in people with Anticoagulants, run by I.M. Sechenov First Moscow State Medical University.
Trial summary
Single-institution uncontrolled open-label trial. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Anticoagulants
- What is being tested?
- prescribing anticoagulant therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2014to 2 Mar 2021
- Phase
- Interventional
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the age above 18
- indications for the anticoagulant therapy
- informed consent for inclusion into trials
Who cannot join
- denial to proceed in the trial
- Non-inclusion criteria:
- pregnancy and lactation
- Intracerebral hemorrhage within three preceding months
- severe mental disorders* which could possibly affect the anticoagulant therapy dosage schedule
- anemia and a decrease in Hb by ˂100 GM/DL*
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- active gastroduodenal ulcer
- active bleeding during the preceding month
- other intensive bleeding instances as per the TIMI Score within three weeks before the inclusion
- severe hepatic impairment for over 10 points under the Child-Pugh Score
- oncology disease with the life expectancy less than one year
About this study
Official title: Optimization of Anticoagulant Therapy in Outpatient Practice
Single-institution uncontrolled open-label trial.
Read the detailed description
The single-institution uncontrolled open-label trial is to optimize the anticoagulant therapy in the out-patient practice.
The study embraces patients who are advised to take the anticoagulant therapy for some reasons. The study has two phases - a retrospective part and a concurrent part. At the first phase, researchers analyze the compliance with the anticoagulant therapy in the real clinical practice. At the concurrent phase, researchers conduct a single-institution uncontrolled open-label trial to evaluate the effectiveness, safety of the anticoagulant therapy and compliance with it at the antithrombotic therapy control ward, and estimate the glomerular filtration rate in patients taking the anticoagulant therapy.
- Conditions
- Anticoagulants
- Being tested
- prescribing anticoagulant therapy
- Keywords
- Rivaroxaban Dabigatran Apixaban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prescribing anticoagulant therapyOther
Patients who need anticoagulants were consulted by a cardiologist with subsequent recommendations
| Study group | Role | What they receive |
|---|---|---|
| anticoagulants arm | Other | The study embraces patients who are advised to take the anticoagulant therapy (as per the European Society of Cardiology Guidelines). The study evaluates the compliance with the anticoagulant therapy, safety and effectiveness, mortality Receives: Other: prescribing anticoagulant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
kidney compliance with the anticoagulant therapy and its safety and trends in the kidney function
During a visit to the clinic, the patient will be surveyed and tested for the creatinine level
Measured: Evaluation of GFR, bleeding and thrombotic complications after 2 years
death due to any cause
phone survey when patients are invited to the clinic
Measured: in six years after the anticoagulant therapy is prescribed
cardiovascular mortality
Phone survey when patients are invited to the clinic. The term cardiovascular mortality means a set of fatal heart attacks, fatal strokes, sudden death, fatal thromboembolism.
Measured: Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 2 years
kidney function trend
phone survey when patients are invited to the clinic for testing the creatinine level and further estimation of the glomerular filtration rate
Measured: Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 3 years
intensive bleeding
phone survey when patients are invited to the clinic.
Measured: Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 6 years
Secondary outcomes (1)
frequency of thromboembolic events
patients will be surveyed upon their visit to the clinic. Thromboembolic events shall mean non-fatal embolic strokes, systemic embolism, acute coronary syndrome (to be corroborated with documents).
Measured: in 1-2-3-6 years after the anticoagulant therapy is prescribed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start15 Jan 2014
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnticoagulantsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zukhra Salpagarova, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319340
- Sponsor's protocol ID
- 678657
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ethics committee requirement
Publications
Chashkina MI, Kozlovskaya NL, Andreev DA, Ananicheva NA, Bykova AA, Salpagarova ZK, Syrkin AL. [Prevalence of Advanced Chronic Kidney Disease in Patients with Nonvalvular Atrial Fibrillation Hospitalized in Cardiology Departments]. Kardiologiia. 2020 Mar 5;60(2):41-46. doi: 10.18087/cardio.2020.2.n823. Russian.
PubMed 32345197
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Anticoagulant Therapy in Outpatient Practice
- ClinicalTrials.gov ID
- NCT05319340
- Acronym / sponsor ID
- 678657
- Conditions
- Anticoagulants
- Keywords
- Rivaroxaban Dabigatran Apixaban
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 15 Jan 2014
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 8 Apr 2022 (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.
Single-institution uncontrolled open-label trial.
Detailed description
The single-institution uncontrolled open-label trial is to optimize the anticoagulant therapy in the out-patient practice.
The study embraces patients who are advised to take the anticoagulant therapy for some reasons. The study has two phases - a retrospective part and a concurrent part. At the first phase, researchers analyze the compliance with the anticoagulant therapy in the real clinical practice. At the concurrent phase, researchers conduct a single-institution uncontrolled open-label trial to evaluate the effectiveness, safety of the anticoagulant therapy and compliance with it at the antithrombotic therapy control ward, and estimate the glomerular filtration rate in patients taking the anticoagulant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anticoagulants arm | Other | Other: prescribing anticoagulant therapyThe study embraces patients who are advised to take the anticoagulant therapy (as per the European Society of Cardiology Guidelines). The study evaluates the compliance with the anticoagulant therapy, safety and effectiveness, mortality |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the age above 18
- indications for the anticoagulant therapy
- informed consent for inclusion into trials
Key exclusion criteria (11 listed)
- denial to proceed in the trial
- pregnancy and lactation
- Intracerebral hemorrhage within three preceding months
- severe mental disorders* which could possibly affect the anticoagulant therapy dosage schedule
- anemia and a decrease in Hb by ˂100 GM/DL*
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 |
|---|---|---|
| prescribing anticoagulant therapyPatients who need anticoagulants were consulted by a cardiologist with subsequent recommendations | Other | anticoagulants arm |
Primary outcome
kidney compliance with the anticoagulant therapy and its safety and trends in the kidney function
Time frame: Evaluation of GFR, bleeding and thrombotic complications after 2 years
During a visit to the clinic, the patient will be surveyed and tested for the creatinine level
death due to any cause
Time frame: in six years after the anticoagulant therapy is prescribed
phone survey when patients are invited to the clinic
cardiovascular mortality
Time frame: Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 2 years
Phone survey when patients are invited to the clinic. The term cardiovascular mortality means a set of fatal heart attacks, fatal strokes, sudden death, fatal thromboembolism.
kidney function trend
Time frame: Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 3 years
phone survey when patients are invited to the clinic for testing the creatinine level and further estimation of the glomerular filtration rate
intensive bleeding
Time frame: Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 6 years
phone survey when patients are invited to the clinic.
1 secondary outcome
frequency of thromboembolic events
Time frame: in 1-2-3-6 years after the anticoagulant therapy is prescribed
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 8 Apr 2022.
- Background: PubMed 32345197Chashkina MI, Kozlovskaya NL, Andreev DA, Ananicheva NA, Bykova AA, Salpagarova ZK, Syrkin AL. [Prevalence of Advanced Chronic Kidney Disease in Patients with Nonvalvular Atrial Fibrillation Hospitalized in Cardiology Departments]. Kardiologiia. 2020 Mar 5;60(2):41-46. doi: 10.18087/cardio.2020.2.n823. Russian.
- Individual participant dataSharing planned: No. ethics committee requirement
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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.
Zukhra Salpagarova principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Questions about this trial
What is this clinical trial studying?
A study testing prescribing anticoagulant therapy in people with Anticoagulants, run by I.M. Sechenov First Moscow State Medical University.
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 3 inclusion and 11 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 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
kidney compliance with the anticoagulant therapy and its safety and trends in the kidney function (time frame: Evaluation of GFR, bleeding and thrombotic complications after 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05319340, which also lists 1 linked publication.
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 8 Apr 2022.