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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.
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 scoreā„2 and/or HAS-BLED scoreā„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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bivalurudin | Experimental | Bivalirudin will be given as a bolus of 0.75 mg/kg once transseptal puncture is successully performed with no pericardial effusion. An additional bivalirudin bolus of 0.3 mg/kg was given if the activated clotting time 5 minutes after the initial bolus was less than 225 seconds. |
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| heparin | Active Comparator | Heparin will be administered at a dose of 70 to 100 units per kilogram in patients not receiving glycoprotein IIb/IIIa inhibitors. Subsequent adjustment of the heparin dose on the basis of the activated clotting time will be left to the discretion of the treating physicians. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalirudin | Drug | Patients would be given anticoagulant therapy with bivalirudin in left atrial appendage occusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | a composite of all cause death, stroke | 7 days |
| Major bleeding | BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Creatine kinase-MB increase | creatine kinase-MB increase >3 times upper limit of normal | up to postprocedural 72 hours |
| Major bleeding | BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding |
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Inclusion Criteria:
Exclusion Criteria:
Left atrial diameterā„65mm;Severe mitral regurgitationļ¼percardial effusion>3mmļ¼LVEF<35%;
Peri-procedual thrombus in left atrial and/or left atrial appendage confirmed by TEE;
Other comorbidities requiring for use of anticoagulants.
Life expectancy ā„ 1 year;
CHA2DS2 score ā¤1 and HAS-BLED scoreā¤2;
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;
Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intra-cerebral mass, aneurysm, etc.);
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 ā„ ā ¢) Complicated with immune system diseasesļ¼
Abnormal hematopoietic systemļ¼platelet count < 100 * 109 / L or > 700 * 109 / Lļ¼white blood cell count < 3 * 109/L etc;
Suffering from acute infections ,infectious diseases or other serious diseases, such as malignant tumors;
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;
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
Patient's inability to fully cooperate with the study protocol
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XIAOCHUN ZHANG, MD | Contact | 8615002121366 | 514864787@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| XIAOCHUN ZHANG, MD | Department of Cardiology, Zhongshan Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hopital of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| C074619 | bivalirudin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Heparin | Drug | heparin during left atrial appendage occlusion. |
|
| 60 days |
| Major adverse cardiac events | a composite of all cause death, strokeļ¼heart failure | 60 days |
| Device-related thrombus | rate of stent thrombosis | 60 days |