Multi-center Application of Bivalirudin in Left Atrial Appendage Occlusion

December 10, 2019 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hopital of Fudan University
        • Contact:
          • XIAOCHUN ZHANG, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bivalurudin
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.
Patients would be given anticoagulant therapy with bivalirudin in left atrial appendage occusion.
Active Comparator: heparin
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.
heparin during left atrial appendage occlusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events
Time Frame: 7 days
a composite of all cause death, stroke
7 days
Major bleeding
Time Frame: 7 days
BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: XIAOCHUN ZHANG, MD, Department of Cardiology, Zhongshan Hospital, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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