Multi-center Application of Bivalirudin in Left Atrial Appendage Occlusion

Evaluate the Safety and Efficacy of Bivalirudin in Decreasing Bleeding Risk Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04195997
• Other study ID #: ZS-2018-81
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2019
• Source: Shanghai Zhongshan Hospital
• Contact: XIAOCHUN ZHANG, MD
• Phone: 8615002121366
• Email: 514864787[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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 = ?) 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Bivalirudin
Patients would be given anticoagulant therapy with bivalirudin in left atrial appendage occusion.
• Heparin
heparin during left atrial appendage occlusion.

Locations

Country	Name	City	State
China	Zhongshan Hopital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events	a composite of all cause death, stroke	7 days
Primary	Major bleeding	BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding	7 days
Secondary	Creatine kinase-MB increase	creatine kinase-MB increase >3 times upper limit of normal	up to postprocedural 72 hours
Secondary	Major bleeding	BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding	60 days
Secondary	Major adverse cardiac events	a composite of all cause death, stroke,heart failure	60 days
Secondary	Device-related thrombus	rate of stent thrombosis	60 days