Multi-center Application of Bivalirudin in Left Atrial Appendage Occlusion

NCT04195997 | Unknown Phase 4 FDA Drug

• 1 other identifier: ZS-2018-81
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Evaluate the Safety and Efficacy of Bivalirudin in Decreasing Bleeding Risk

Outcome Measures

Primary Outcomes (2)

• Major adverse cardiac events

  a composite of all cause death, stroke

  7 days

• Major bleeding

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

  7 days

Secondary Outcomes (4)

• Creatine kinase-MB increase

  up to postprocedural 72 hours

• Major bleeding

  60 days

• Major adverse cardiac events

  60 days

• Device-related thrombus

  60 days

Study Arms (2)

bivalurudin

EXPERIMENTAL

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.

Drug: Bivalirudin

heparin

ACTIVE COMPARATOR

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.

Drug: Heparin

Interventions

Bivalirudin DRUG

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

bivalurudin

Heparin DRUG

heparin during left atrial appendage occlusion.

heparin

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hopital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

bivalirudin; Heparin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• XIAOCHUN ZHANG, MD

  Department of Cardiology, Zhongshan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

XIAOCHUN ZHANG, MD

CONTACT

8615002121366; 514864787@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: February 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: June 30, 2021
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

CN (1)