Current partner codePEPTIDESDE
NCT04195997·Phase 4·INTERVENTIONAL

Multi-center Application of Bivalirudin in Left Atrial Appendage Occlusion

Status

Unknown

Phase

Phase 4

Enrollment

100

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Bivalirudin

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

DRUG

Heparin

heparin during left atrial appendage occlusion.

Timeline

From registration to results.

  1. First posted

    Dec 12, 2019

  2. Study start

    Feb 1, 2020

  3. Primary completion

    Dec 30, 2020

  4. Study completion

    Jun 30, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Dec 12, 2019

Outcomes

What the study measures.

Primary outcomes

Major adverse cardiac events

Time frame · 7 days

a composite of all cause death, stroke

Major bleeding

Time frame · 7 days

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

Secondary outcomes

Creatine kinase-MB increase

Time frame · up to postprocedural 72 hours

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

Major bleeding

Time frame · 60 days

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

Major adverse cardiac events

Time frame · 60 days

a composite of all cause death, stroke,heart failure

Device-related thrombus

Time frame · 60 days

rate of stent thrombosis

Eligibility

Who can take part.

Minimum age
60 Years
Maximum age
85 Years
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Zhongshan Hopital of Fudan University

Shanghai, Shanghai Municipality, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

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