An analysis on distribution of biomarkers and soluble fibrin monomer complex (SFMC) at trough under direct oral anticoagulants (DOACs) in non-valvular atrial fibrillation patients with CHA2DS2-VASc score greater than 2 (CVI ARO 13)

An analysis on distribution of biomarkers and soluble fibrin monomer complex (SFMC) at trough under direct oral anticoagulants (DOACs) in non-valvular atrial fibrillation patients with CHA2DS2-VASc score greater than 2 (CVI ARO 13) - CVI ARO 13 Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051183

Enrollment

100

Registered

2023-05-29

Start date

2020-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) CHA2DS2-VASc score higher than 2; (2) under the treatment with or intended to use direct factor Xa inhibitor (FXaI; rivaroxaban, apixaban, or edoxaban) in order to prevent stroke or systemic embolism by AF; (3) older than 20 years old at the enrollment; and (4) with written informed consent.

Exclusion criteria

Exclusion criteria: Patients with any of the following at the enrollment were excluded; (1) receiving antiplatelet therapy, (2) inadequate dosage of FXaI with the Japanese pharmaceutical reference; (3) FXaI hypersensitivity; (4) patients with active bleeding (intracranial hemorrhage or retroperitoneal hemorrhage or bleeding in other important organs); (5) patients with acute bacterial endocarditis; (6) renal dysfunction (creatinine clearance < 30 mL/min); (7) liver dysfunction with clotting disorder; (8) cardiovascular event (stroke, myocardial infarction, percutaneous coronary intervention, and admission with heart failure) or major bleeding with admission before one month of enrollment, (9) patients who did not provide written informed consent; and (10) patients who were judged by the researchers to be inappropriate for this study (i.e., incapable of understanding the study protocol due to dementia, intellectual disturbance, and/or psychiatric/psychosomatic disorder).

Design outcomes

Primary

Measure	Time frame
1. 90% interval of DOAC concentration 2. Relationship between DOAC concentration and SFMC and D-dimer 3. Relationship between DOAC and relevant coagulation markers and inflammatory markers	—

Secondary

Measure	Time frame
Adverse events during follow up period. 1. Death (all-cause death, cardiovascular death, non cardiovascular death) 2. Stroke (ischemic stroke, intracranial hemorrhage, other) 3. Systemic embolism 4. Major bleeding needing hospitalization 5. Cardiovascular event needing hospitalization 6. Othrer	—

Countries

Japan

Contacts

Public ContactKazumi Matsuda

Cardiovascular Institute Academic Reserch Organization (CVI ARO) Head Office

matsuda@cvi.or.jp03-3408-2151

Outcome results