ThromboembolismNCT06627933
Optimization of Management in Patients With Cardiovascular Disease After Lower Limb Joint Replacement
An observational study of Thromboembolism and Anticoagulant-induced Bleeding, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
The goal of the study is to evaluate the frequency of cardiovascular and thromboembolic complications in patients with cardiovascular disease after lower limb joint replacement, the influence of known risk factors and strategies for perioperative prevention of thromboembolic complications on the frequency of… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Thromboembolism, Anticoagulant-induced Bleeding
- How many people
- 1,733 participants
- Where
- 1 siteRussia
- Study dates
- 15 Jan 2023to 10 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study is planned to include 1,000 patients with cardiovascular diseases who undergo routine endoprosthetics of large joints of the lower extremities. During the follow-up, patients will be divided into subgroups depending on the scheme of perioperative prevention of thromboembolic complications and the presence of risk factors. The comparison will be carried out in the appropriate subgroups.
Who may be able to join
- Informed consent
- Age older than 18 y.o.
- Cardiovascular disease
- Indications for planned lower limb joint replacement surgery
Who cannot join
- Pregnancy
- Psychiatric disorders
- Decompensated heart failure or acute heart failure
- Known diagnosis of cancer
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the study is to evaluate the frequency of cardiovascular and thromboembolic complications in patients with cardiovascular disease after lower limb joint replacement, the influence of known risk factors and strategies for perioperative prevention of thromboembolic complications on the frequency of cardiovascular complications and to develop approaches to optimize antithrombotic prevention tactics.
- Conditions
- Thromboembolism, Anticoagulant-induced Bleeding
- Being tested
- No intervention
- Keywords
- joint replacement, prognosis, anticoagulation regimen, thromboembolism, venous thromboembolism
- Medical subject headings
- Thromboembolism, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Low thromboembolic risk | Not described | |
| Moderate thromboembolic risk | Not described | |
| High thromboembolic risk | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding
All the cases of major and minor bleeding within 1 month
Measured: 1 month
Bleeding
All the cases of major and minor bleeding within 3 months
Measured: 3 months
Bleeding
All the cases of major and minor bleeding within 6 months
Measured: 6 months
Thromboembolism
All the cases of venous thromboembolism within 1 month
Measured: 1 month
Thromboembolism
All the cases of venous thromboembolism within 3 months
Measured: 3 months
Thromboembolism
All the cases of venous thromboembolism within 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start15 Jan 2023
- Primary completion15 Jan 2025
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,733 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Trushina, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627933
- Sponsor's protocol ID
- 11-23
- Status last verified
- May 2026
- First submitted
- 3 Oct 2024
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Okisheva EA, Mironova OI, Berdysheva MV, Pyatigorets ES, Krivova NP, Kurnosova AA, Elizarov MP, Smetanin SM, Lychagin AV, Fomin VV. [Relationship between the pain severity, use of non-steroidal anti-inflammatory drugs and blood pressure in elective large joint arthroplasty of the lower extremities]. Ter Arkh. 2023 Nov 3;95(9):751-756. doi: 10.26442/00403660.2023.09.202373. Russian.
PubMed 38158917Okisheva EA, Trushina OY, Mamaeva MM, Redyanova EA, Zhazhieva AA, Chasova ID, Panferov AS, Bogdanov MM, Lychagin AV, Fomin VV. [Glucose metabolism disorders and hypoglycemic therapy in patients hospitalized for elective lower limb arthroplasty: a prospective, single-center, real-world study]. Ter Arkh. 2024 Jul 30;96(7):659-665. doi: 10.26442/00403660.2024.07.202780. Russian.
PubMed 39106508
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Management in Patients With Cardiovascular Disease After Lower Limb Joint Replacement
- ClinicalTrials.gov ID
- NCT06627933
- Acronym / sponsor ID
- 11-23
- Conditions
- Thromboembolism, Anticoagulant-induced Bleeding
- Keywords
- joint replacement, prognosis, anticoagulation regimen, thromboembolism, venous thromboembolism
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,733 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 4 Oct 2024 (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.
The goal of the study is to evaluate the frequency of cardiovascular and thromboembolic complications in patients with cardiovascular disease after lower limb joint replacement, the influence of known risk factors and strategies for perioperative prevention of thromboembolic complications on the frequency of cardiovascular complications and to develop approaches to optimize antithrombotic prevention tactics.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low thromboembolic risk | – | – |
| Moderate thromboembolic risk | – | – |
| High thromboembolic risk | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is planned to include 1,000 patients with cardiovascular diseases who undergo routine endoprosthetics of large joints of the lower extremities. During the follow-up, patients will be divided into subgroups depending on the scheme of perioperative prevention of thromboembolic complications and the presence of risk factors. The comparison will be carried out in the appropriate subgroups.
Key inclusion criteria (4 listed)
- Informed consent
- Age older than 18 y.o.
- Cardiovascular disease
- Indications for planned lower limb joint replacement surgery
Key exclusion criteria (4 listed)
- Pregnancy
- Psychiatric disorders
- Decompensated heart failure or acute heart failure
- Known diagnosis of cancer
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 |
|---|---|---|
| No interventionNo intervention | Other | High thromboembolic risk |
Primary outcome
Bleeding
Time frame: 1 month
All the cases of major and minor bleeding within 1 month
Bleeding
Time frame: 3 months
All the cases of major and minor bleeding within 3 months
Bleeding
Time frame: 6 months
All the cases of major and minor bleeding within 6 months
Thromboembolism
Time frame: 1 month
All the cases of venous thromboembolism within 1 month
Thromboembolism
Time frame: 3 months
All the cases of venous thromboembolism within 3 months
Thromboembolism
Time frame: 6 months
All the cases of venous thromboembolism within 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 38158917Okisheva EA, Mironova OI, Berdysheva MV, Pyatigorets ES, Krivova NP, Kurnosova AA, Elizarov MP, Smetanin SM, Lychagin AV, Fomin VV. [Relationship between the pain severity, use of non-steroidal anti-inflammatory drugs and blood pressure in elective large joint arthroplasty of the lower extremities]. Ter Arkh. 2023 Nov 3;95(9):751-756. doi: 10.26442/00403660.2023.09.202373. Russian.
- Results publication: PubMed 39106508Okisheva EA, Trushina OY, Mamaeva MM, Redyanova EA, Zhazhieva AA, Chasova ID, Panferov AS, Bogdanov MM, Lychagin AV, Fomin VV. [Glucose metabolism disorders and hypoglycemic therapy in patients hospitalized for elective lower limb arthroplasty: a prospective, single-center, real-world study]. Ter Arkh. 2024 Jul 30;96(7):659-665. doi: 10.26442/00403660.2024.07.202780. Russian.
- Individual participant dataSharing planned: Undecided
Related trials for Thromboembolism
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thromboembolism and Anticoagulant-induced Bleeding, run by I.M. Sechenov First Moscow State Medical University 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Bleeding (time frame: 1 month). The study lists 6 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 NCT06627933, which also lists 2 linked publications.
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 14 May 2026.