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Multi-center Application of Bivalirudin in Left Atrial Appendage Occlusion

Primary Purpose

Evaluate the Safety and Efficacy of Bivalirudin in Decreasing Bleeding Risk

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Bivalirudin

Heparin

About this trial

This is an interventional treatment trial for Evaluate the Safety and Efficacy of Bivalirudin in Decreasing Bleeding Risk

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Left atrial diameter≥65mm;Severe mitral regurgitation；percardial effusion>3mm；LVEF<35%;
Peri-procedual thrombus in left atrial and/or left atrial appendage confirmed by TEE;
Other comorbidities requiring for use of anticoagulants.
Life expectancy ≥ 1 year;
CHA2DS2 score ≤1 and HAS-BLED score≤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 ≥ Ⅲ) Complicated with immune system diseases；
Abnormal hematopoietic system：platelet count < 100 * 109 / L or > 700 * 109 / L，white 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

Sites / Locations

Zhongshan Hopital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

bivalurudin

heparin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Major adverse cardiac events

a composite of all cause death, stroke

Major bleeding

BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding

Secondary Outcome Measures

Creatine kinase-MB increase

creatine kinase-MB increase >3 times upper limit of normal

Major bleeding

BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding

Major adverse cardiac events

a composite of all cause death, stroke，heart failure

Device-related thrombus

rate of stent thrombosis

Full Information

NCT ID

NCT04195997

First Posted

December 10, 2019

Last Updated

December 10, 2019

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04195997

Brief Title

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

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2020 (Anticipated)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Evaluate the Safety and Efficacy of Bivalirudin in Decreasing Bleeding Risk

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

bivalurudin

Arm Type

Experimental

Arm Description

Arm Title

heparin

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bivalirudin

Intervention Description

Patients would be given anticoagulant therapy with bivalirudin in left atrial appendage occusion.

Intervention Type

Drug

Intervention Name(s)

Heparin

Intervention Description

heparin during left atrial appendage occlusion.

Primary Outcome Measure Information:

Title

Major adverse cardiac events

Description

a composite of all cause death, stroke

Time Frame

7 days

Title

Major bleeding

Description

BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Creatine kinase-MB increase

Description

creatine kinase-MB increase >3 times upper limit of normal

Time Frame

up to postprocedural 72 hours

Title

Major bleeding

Description

BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding

Time Frame

60 days

Title

Major adverse cardiac events

Description

a composite of all cause death, stroke，heart failure

Time Frame

60 days

Title

Device-related thrombus

Description

rate of stent thrombosis

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age older than 60 years; non-valvular atrial fibrillation patients with contraindication for long-term oral anticoagulant or occurrence or stroke in spite of regular administration of medication; CHA2DS2 score≥2 and/or HAS-BLED score≥3; Provide written informed consent. Exclusion Criteria: Left atrial diameter≥65mm;Severe mitral regurgitation；percardial effusion>3mm；LVEF<35%; Peri-procedual thrombus in left atrial and/or left atrial appendage confirmed by TEE; Other comorbidities requiring for use of anticoagulants. Life expectancy ≥ 1 year; CHA2DS2 score ≤1 and HAS-BLED score≤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 ≥ Ⅲ) Complicated with immune system diseases； Abnormal hematopoietic system：platelet count < 100 * 109 / L or > 700 * 109 / L，white 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

XIAOCHUN ZHANG, MD

Phone

8615002121366

514864787@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

XIAOCHUN ZHANG, MD

Organizational Affiliation

Department of Cardiology, Zhongshan Hospital, Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hopital of Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

XIAOCHUN ZHANG, MD

12. IPD Sharing Statement

Learn more about this trial

Multi-center Application of Bivalirudin in Left Atrial Appendage Occlusion

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