NCT06627933

Brief 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 cardiovascular complications and to develop approaches to optimize antithrombotic prevention tactics.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jan 2023Jan 2027

Study Start

First participant enrolled

January 15, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Expected
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

October 3, 2024

Last Update Submit

October 7, 2024

Conditions

ThromboembolismAnticoagulant-induced Bleeding

Keywords

joint replacementprognosisanticoagulation regimenthromboembolismvenous thromboembolism

Outcome Measures

Primary Outcomes (6)

  • Bleeding

    All the cases of major and minor bleeding within 1 month

    1 month

  • Bleeding

    All the cases of major and minor bleeding within 3 months

    3 months

  • Bleeding

    All the cases of major and minor bleeding within 6 months

    6 months

  • Thromboembolism

    All the cases of venous thromboembolism within 1 month

    1 month

  • Thromboembolism

    All the cases of venous thromboembolism within 3 months

    3 months

  • Thromboembolism

    All the cases of venous thromboembolism within 6 months

    6 months

Study Arms (3)

Low thromboembolic risk

Moderate thromboembolic risk

High thromboembolic risk

Other: No intervention

Interventions

No interventionOTHER

No intervention

High thromboembolic risk

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Informed consent
  • Age older than 18 y.o.
  • Cardiovascular disease
  • Indications for planned lower limb joint replacement surgery

You may not qualify if:

  • Pregnancy
  • Psychiatric disorders
  • Decompensated heart failure or acute heart failure
  • Known diagnosis of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital #1

Moscow, 119991, Russia

RECRUITING

Related Publications (2)

  • 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.

    PMID: 38158917BACKGROUND

  • Okisheva 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.

    PMID: 39106508RESULT

MeSH Terms

Conditions

ThromboembolismVenous Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Central Study Contacts

Elena Okisheva, MD, PhD

CONTACT

+79161162393e.okisheva@gmail.com

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 4, 2024

Study Start

January 15, 2023

Primary Completion

January 15, 2025

Study Completion (Estimated)

January 15, 2027

Last Updated

October 9, 2024

Record last verified: 2024-10

Locations

RU(1)