- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04195997
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
Status
Unknown
Intervention / Treatment
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
- Name: XIAOCHUN ZHANG, MD
- Phone Number: 8615002121366
- Email: 514864787@qq.com
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200032
- Zhongshan Hopital of Fudan University
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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:
- 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
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.
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Patients would be given anticoagulant therapy with bivalirudin in left atrial appendage occusion.
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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.
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heparin during left atrial appendage occlusion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiac events
Time Frame: 7 days
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a composite of all cause death, stroke
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7 days
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Major bleeding
Time Frame: 7 days
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BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding
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7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Creatine kinase-MB increase
Time Frame: up to postprocedural 72 hours
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creatine kinase-MB increase >3 times upper limit of normal
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up to postprocedural 72 hours
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Major bleeding
Time Frame: 60 days
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BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding
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60 days
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Major adverse cardiac events
Time Frame: 60 days
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a composite of all cause death, stroke,heart failure
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60 days
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Device-related thrombus
Time Frame: 60 days
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rate of stent thrombosis
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60 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZS-2018-81
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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