Evaluate the Safety and Efficacy of Bivalirudin in Decreasing Bleeding Risk
Conditions
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.
Interventions
DRUGBivalirudin
Patients would be given anticoagulant therapy with bivalirudin in left atrial appendage occusion.
DRUGHeparin
heparin during left atrial appendage occlusion.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events | 7 days | a composite of all cause death, stroke |
| Major bleeding | 7 days | BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creatine kinase-MB increase | up to postprocedural 72 hours | creatine kinase-MB increase \>3 times upper limit of normal |
| Major bleeding | 60 days | BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding |
| Major adverse cardiac events | 60 days | a composite of all cause death, stroke，heart failure |
| Device-related thrombus | 60 days | rate of stent thrombosis |
Countries
China
Contacts
Primary ContactXIAOCHUN ZHANG, MD
Outcome results
None listed