Comparative anti-Factor Xa activity between standard dose and Japanese dose of rivaroxaban in Thai patients with non-valvular atrial fibrillatio

Not Applicable

Completed

• Conditions: on- valvular Atrial Fibrillation.; - Non- valvular Atrial Fibrillation; anti- XA activity; Rivaroxaban standard dose; Rivaroxaban Japanese dose

• Registration Number: TCTR20181104002
• Lead Sponsor: Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-04
• Study Completion: 2019-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Men or women Aged ≥ 18 years
2. Patients with non-valvular AF who have been receiving rivaroxaban
3. Atrial fibrillation must be documented by ECG evidence (e.g., 12-lead ECG, rhythm strip, Holter, pacemaker interrogation) within 30 days before enrolled. In addition, subjects must have medical evidence of atrial fibrillation within 1 year before and at least one day before the qualifying ECG evidence. This could be obtained from a notation in the subject's record (e.g., medical chart, hospital discharge summary).
4. Female subjects must be postmenopausal (for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, have a negative serum β-hCG pregnancy test at screening.
5. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria

1. Patients with severe renal impairment (CrCl<15 mL/min)
2. Cardiac-Related Conditions: Hemodynamically significant mitral valve stenosis, prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted), planned cardioversion (electrical or pharmacological), transient atrial fibrillation caused by a reversible disorder (e.g., thyrotoxicosis, PE, recent surgery, MI), known presence of atrial myxoma or left ventricular thrombus, active endocarditis
3. Hemorrhage Risk-Related Criteria:
• Active internal bleeding
• History of or condition associated with increased bleeding risk
including, but not limited to:
†Major surgical procedure or trauma within 30 days before
the randomization visit
†Clinically significant gastrointestinal bleeding within 6
months before the randomization visit
†History of intracranial, intraocular, spinal, or
atraumatic intra-articular bleeding
†Chronic hemorrhagic disorder
†Known intracranial neoplasm, arteriovenous malformation,
or aneurysm
• Planned invasive procedure with potential for uncontrolled
bleeding, including major surgery
• Platelet count <90,000/μL at the screening visit
• Sustained uncontrolled hypertension: systolic blood pressure
≥180 mmHg or diastolic blood pressure ≥100 mmHg
4. Anemia (hemoglobin <10 g/dL) at the screening visit
5. Pregnancy or breast-feeding
6. Patients with poor compliance to medication
7. Patients who refuse to obtain informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
anti-XA activity Hour 0 and Hour 3 anti-XA level

Secondary Outcome Measures

Name	Time	Method
anti-XA normal activity Hour 0 and Hour 3 anti-XA level