Atrial fibrillation
Conditions
Interventions
Chinese Medicine Treatment Group:Rivaroxaban 10mg+rivaroxaban placebo 10mg/5mg + Wenxin Granules
Western Medicine Control Group:Rivaroxaban 10mg + Rivaroxaban 10mg/5mg + Wenxin Granules placebo
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1) Patients aged =18 years with non-valvular atrial fibrillation, regardless of gender. (2) Objective evidence of atrial high-rate episodes (AHRE) recorded via electrocardiogram, Holter monitor/event recorder, or pacemaker within 30 days prior to randomization (atrial rate >180-220 bpm, duration =5 minutes). Additionally, patients must have documented medical history of AF within 1 year prior to the qualifying electrophysiological evidence, obtainable from clinical records (e.g., medical charts, discharge summaries). (3) Patients with non-valvular atrial fibrillation who are not candidates for or have no intention to undergo cardioversion. (4) CHA2DS2-VASc-60 score =2 (male) or =3 (female) AND HAS-BLED score =3. (5) Provision of informed consent and voluntary commitment to the follow-up schedule.
Exclusion criteria
Exclusion criteria: (1) Mechanical heart valves (excluding transcatheter aortic valve replacement). (2) Moderate to severe mitral stenosis present at the time of study enrollment. (3) Atrial fibrillation caused solely by reversible causes (e.g., hyperthyroidism, pulmonary embolism, myocardial infarction, recent surgery, etc.). (4) Known presence of left atrial appendage or left ventricular thrombus. (5) Contraindications to anticoagulant therapy (1) severe active bleeding; 2) comorbidities associated with bleeding, such as severe thrombocytopenia (platelet count 100 mg, or aspirin combined with thienopyridine within 5 days prior to randomization, or intravenous antiplatelet agents within 5 days prior to randomization, or fibrinolytic therapy within 10 days prior to randomization (Note: Aspirin monotherapy =100 mg daily is permitted; thienopyridine monotherapy is permitted). (7) Pregnant or lactating women, or individuals with positive pregnancy test results prior to randomization. (8) Recent ischemic stroke (within 7 days prior to randomization). (9) Major surgery within 30 days prior to randomization. (10) Life expectancy less than 3 years or presence of other severe diseases affecting follow-up. (11) Concurrent participation in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of composite cardiovascular and cerebrovascular endpoint events after 1 year of treatment (including stroke, systemic embolism, transient ischemic attack, myocardial infarction, cardiova;Incidence of ISTH-defined major bleeding events and clinically relevant non-major bleeding events after 1-year treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of composite cardiovascular and cerebrovascular endpoint events at 2 and 3 years post-treatment;Incidence of major bleeding events and clinically relevant non-major bleeding events at 2 and 3 years post-treatment;Traditional Chinese Medicine(TCM) syndrome efficacy score at each post-treatment visit point;Quality of life scores at 1, 2, and 3 years post-treatment; | — |
Countries
People's Republic of China
Contacts
Public ContactHu Xiaosheng
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed