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Low-dose rivaroxaban versus standard-dose antithrombotic therapy after left atrial appendage occlusion: a randomized controlled trial

Low-dose rivaroxaban versus standard-dose antithrombotic therapy after left atrial appendage occlusion: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080549
Enrollment
Unknown
Registered
2024-02-01
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

atrial

Interventions

Low-dose rivaroxaban anticoagulation group: Reduced dose of rivaroxaban (15/10mg/d: creatinine clearance rate > 50ml/min, 15mg/d
creatinine clearance rate = 50ml/min = 30ml/min, 10mg/d) for anticoagulation until 45 days after surgsurgery (patients who underwent AF catheter ablation combined with LAAO used it until 2 months afte
Standard-dose antithrombotic therapy : Standard dose of rivaroxaban (20/15mg/d: creatinine clearance rate > 50ml/min, 20mg/d
creatinine clearance rate = 50ml/min = 30ml/min, 15mg/d) (patients who underwent AF catheter ablation combined with LAAO used it until 2 months after operation), it was changed to DAPT (aspirin 100mg/

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Non-valvular atrial fibrillation patients aged 18 to 80 years with a life expectancy greater than 1 year 2. Left atrial appendage closure was successfully performed and Watchman left atrial appendage closure device was implanted (including the one-stop operation of LAAO and AF catheter ablation combined with LAAO) without complications 3. Sign the informed consent form

Exclusion criteria

Exclusion criteria: Severe hepatic and renal dysfunction: Alanine aminotransferase or aspartate aminotransferase levels increase more than 3 times the upper limit of normal; creatinine clearance rate < 30ml/min. Other clinical studies that have been registered and hospitalized may affect the research objectives. The investigator believes that the subject's physical condition is not suitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
non-procedural ischemic stroke;non-procedural systemic embolization;Device-related thrombus;Major bleeding;

Secondary

MeasureTime frame
Minor bleeding;

Countries

China

Contacts

Public ContactFangyi Xiao

The First Affiliated Hospital of Wenzhou Medical University

harry686896@126.com+86 135 6628 6896

Outcome results

None listed

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