Clinical trial NCT04195997: Multi-center Application of Bivalirudin in Left Atrial Appendage Occlusion
Official title: Multi-center Application of Bivalirudin in High-risk Bleeding Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Left Atrial Appendage Occlusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Evaluate the Safety and Efficacy of Bivalirudin in Decreasing Bleeding Risk
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age older than 60 years;
2. non-valvular atrial fibrillation patients with contraindication for long-term oral anticoagulant or occurrence or stroke in spite of regular administration of medication;
3. CHA2DS2 score≥2 and/or HAS-BLED score≥3;
4. Provide written informed consent.

Exclusion Criteria:

1. Left atrial diameter≥65mm;Severe mitral regurgitation；percardial effusion\>3mm；LVEF\<35%;
2. Peri-procedual thrombus in left atrial and/or left atrial appendage confirmed by TEE;
3. Other comorbidities requiring for use of anticoagulants.
4. Life expectancy ≥ 1 year;
5. CHA2DS2 score ≤1 and HAS-BLED score≤2;
6. Active bleeding or bleeding constitution, bleeding tendency, including GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc;
7. Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intra-cerebral mass, aneurysm, etc.);
8. Severe renal insufficiency (eGFR \< 30 mL/min/ 1.73 m2); Elevated AST, ALT level higher than three times of the normal upper limit; Advanced heart failure (NYHA classification grading of cardiac function ≥ Ⅲ) Complicated with immune system diseases；
9. Abnormal hematopoietic system：platelet count \< 100 \* 109 / L or \> 700 \* 109 / L，white blood cell count \< 3 \* 109/L etc;
10. Suffering from acute infections ,infectious diseases or other serious diseases, such as malignant tumors;
11. Known intolerance, or contraindication to any antithrombotic medication Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.

    Non-cardiac co-morbid conditions are present that may result in protocol non-compliance;
12. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
13. Patient's inability to fully cooperate with the study protocol

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 7 days
measure: Major bleeding
timeFrame: 7 days
Secondary outcomes:
measure: Creatine kinase-MB increase
timeFrame: up to postprocedural 72 hours
measure: Major bleeding
timeFrame: 60 days
measure: Major adverse cardiac events
timeFrame: 60 days
measure: Device-related thrombus
timeFrame: 60 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hopital of Fudan University
state: Shanghai
Study officials:
affiliation: Department of Cardiology, Zhongshan Hospital, Fudan University
name: XIAOCHUN ZHANG, MD
role: PRINCIPAL_INVESTIGATOR
References: