I.M. Sechenov First Moscow State Medical University (Sechenov University)

• Sponsor: I.M. Sechenov First Moscow State Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05319340
• Collaborator: (none)
• Enrollment: 1,000
• Arm: 1
• Duration (Months): 85.5

Study Details

Study Description

Brief Summary

Single-institution uncontrolled open-label trial.

Condition or Disease	Intervention/Treatment	Phase
Anticoagulants	Other: prescribing anticoagulant therapy	N/A

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

• Study Type: Interventional
• Actual Enrollment: 1000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Optimization of Anticoagulant Therapy in Outpatient Practice
• Study Start Date: Jan 15, 2014
• Actual Primary Completion Date: Mar 2, 2021
• Actual Study Completion Date: Mar 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: anticoagulants arm 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	Other: prescribing anticoagulant therapy; Patients who need anticoagulants were consulted by a cardiologist with subsequent recommendations

Outcome Measures

Primary Outcome Measures

1. kidney compliance with the anticoagulant therapy and its safety and trends in the kidney function [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

2. death due to any cause [in six years after the anticoagulant therapy is prescribed]

   phone survey when patients are invited to the clinic

3. cardiovascular mortality [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.

4. kidney function trend [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

5. intensive bleeding [Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 6 years]

   phone survey when patients are invited to the clinic.

Secondary Outcome Measures

1. frequency of thromboembolic events [in 1-2-3-6 years after the anticoagulant therapy is prescribed]

   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).

Other Outcome Measures

1. minor bleeding [in 1-2-3-6 years after the anticoagulant therapy is prescribed]

   Minor bleeding shall mean any visually observed bleeding, including that discovered with various imaging methods, which cause a decrease in HB by less than 30 GM/DL or Ht by less than 9%.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• the age above 18

• indications for the anticoagulant therapy

• informed consent for inclusion into trials

Exclusion Criteria:

• 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*

• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• I.M. Sechenov First Moscow State Medical University

Investigators

• Principal Investigator: Zukhra Salpagarova, I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: I.M. Sechenov First Moscow State Medical University
• ClinicalTrials.gov Identifier: NCT05319340
• Other Study ID Numbers: 678657
• First Posted: Apr 8, 2022
• Last Update Posted: Apr 8, 2022
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by I.M. Sechenov First Moscow State Medical University: Rivaroxaban Dabigatran Apixaban
• Additional relevant MeSH terms: Anticoagulants

Study Results

No Results Posted as of Apr 8, 2022