NCT04195997

Multi-center Application of Bivalirudin in Left Atrial Appendage Occlusion

Multi-center Application of Bivalirudin in High-risk Bleeding Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Left Atrial Appendage Occlusion

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in patients with non-valvular atrial fibrillation undergoing percutaneous left atrial appendage occlusion.

Detailed description

Bivalirudin, a direct thrombin inhibitor, emerged as an important representative of intravenous anticoagulant and has been recommended for treatment of acute coronary syndromes with percutaneous coronary intervention according to American and European guidelines.On concerns of risk of bleeding and thrombosis,bivalirudin shows significant advantages over traditional glycoprotein inhibitors(GPI).However,the research about the application of bivalirudin for patients at high-risk of stroke and bleeding with non-valvular atrial fibrillation is still at blank stage.Percutaneous left atrial appendage occlusion is nowadays an effective alternative for stroke prevention and its targeted population is featured as CHA2DS2 score≥2 and/or HAS-BLED score≥3.The purpose of this multi-center trial is to evaluate the safety and peri-procedual efficacy of bivalirudin for patients at high-risk atrial fibrillation patients undergoing percutaneous left atrial appendage occlusion.

Conditions

• Evaluate the Safety and Efficacy of Bivalirudin in Decreasing Bleeding Risk

Interventions

Type	Name	Description
DRUG	Bivalirudin	Patients would be given anticoagulant therapy with bivalirudin in left atrial appendage occusion.
DRUG	Heparin	heparin during left atrial appendage occlusion.

Timeline

• Start date: 2020-02-01
• Primary completion: 2020-12-30
• Completion: 2021-06-30
• First posted: 2019-12-12
• Last updated: 2019-12-12

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study