Anticoagulants
Conditions
Keywords
Rivaroxaban Dabigatran Apixaban
Brief summary
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.
Interventions
OTHERprescribing anticoagulant therapy
Patients who need anticoagulants were consulted by a cardiologist with subsequent recommendations
Sponsors
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| death due to any cause | in six years after the anticoagulant therapy is prescribed | phone survey when patients are invited to the clinic |
| 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 |
| intensive bleeding | Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 6 years | phone survey when patients are invited to the clinic. |
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
Outcome results
None listed