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Evaluation of the efficacy and safety of rivaroxaban in patients with valvular atrial fibrillation: A randomized controlled clinical trial protocol

Evaluation of the efficacy and safety of rivaroxaban in patients with valvular atrial fibrillation: A randomized controlled clinical trial protocol

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058611
Enrollment
Unknown
Registered
2022-04-12
Start date
2022-04-06
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

valvular atrial fibrillation

Interventions

Experiment group:rivaroxaban
Control group:warfarin or other treatment

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age = 18 years; 2.Female patients had to be either postmenopausal, surgically sterile, abstinent, or using appropriate birth control before entry and throughout the study, and negative for pregnancy test using serum ß-human chorionic gonadotropin at screening; 3.The diagnosis of valvular AF was based on history, electrocardiogram, ambulatory electrocardiographic monitoring, and clinical findings.

Exclusion criteria

Exclusion criteria: 1. Have a history of heart related diseases (mitral stenosis with significant hemodynamics, artificial heart valves, known presence of cardiac myxoma or left ventricular mural thrombus or active endocarditis); 2. Have a history of serious lung, liver, kidney or nervous system disease or mental disease; 3. The daily dose of aspirin exceeds 165 mg, or aspirin and clopidogrel are taken at the same time; 4. The expected life is less than 1 year; 5. Current alcoholism, drug abuse or psychosocial problems.

Design outcomes

Primary

MeasureTime frame
systemic embolism;stroke;Blooding;

Secondary

MeasureTime frame
the quality of life;adverse events;

Countries

China

Contacts

Public ContactBin Wang

The Second Hospital of Hebei Medical University

wangbin8255@163.com+86 15833917255

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026