A Multi-center Study of Apixaban(APPROACH)

NCT ID: NCT04550637

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-04
• Study Completion Date: 2024-12-31

Brief Summary

The aim of the study is to enroll approximately 200 cases from 10 research centers nationwide, completed left atrial appendage occlusion (LAAO) successfully, and give apixaban (5 mg bid) postoperatively.

Conditions

Evaluate the Safety and Efficacy of Apixaban

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Anticoagulant therapy after percutaneous left atrial appendage

Oral apixaban

Oral apixaban

Intervention Type: DRUG

apixaban (5 mg bid) is given until 12 weeks after surgery

Interventions

Oral apixaban

apixaban (5 mg bid) is given until 12 weeks after surgery

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• age between 18 to 85 years;
• understand the purpose of the trial, sign the informed consent form voluntarily
• successful surgery (no pericardial effusion, pericardial tamponade, or device displacement during operation; no pericardial effusion before discharge), meet COST standard during operation.
• In accordance with the indications for left atrial appendage occlusion: CHA2DS2-VAS2 score≥2 points and/or HAS-BLED score≥3 points
• unable or unwilling to take oral anticoagulants
• life expectancy≥1 year

Exclusion Criteria

• History of previous cardiac surgery (valve disease, cardiomyopathy, severe coronary occlusion);
• Inability to tolerate trans-esophageal echocardiography;
• Preoperative trans-esophageal echocardiography suggests thrombus in left atrial appendage/left atrial;
• Patients with severe renal insufficiency (creatinine clearance rate<15ml/min);
• Patients with liver disease accompanied by abnormal blood coagulation and clinically related bleeding risks;
• Clinically significant active bleeding;
• The baseline platelet count is severely reduced: PLT≤50*10^9/L;
• Severe cardiac insufficiency (preoperative transthoracic echocardiography indicated LVEF <35%; uncontrolled heart failure (NYHA IV))
• Allergy or contraindication to anticoagulant drugs such as aspirin, clopidogrel, apixaban, etc .;
• Serious heart valve disease or other structural abnormalities need do elective surgical treatment; or severe coronary heart disease require limited-term intervention;
• Less than 45kg or more than 100kg.
• Take strong CYP3A4 and P-gp inhibitors (including pyrrole antifungal drugs, HIV protease inhibitors, etc.) for systemic treatment;
• Patients with other diseases besides atrial fibrillation (such as after mechanical valve replacement, spontaneous or recurrent venous thromboembolism, etc.) need anticoagulation treatment;
• Unsuccessful surgery (serious pericardial tamponade, massive bleeding and other life-threatening complications occur within 3 days after left atrial appendage closure);
• Pregnancy or lactation;
• Participating in other uncompleted clinical trials;
• Investigator considers inappropriate subjects.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junbo Ge

Role: STUDY_CHAIR

Fudan University

Locations

Zhongshan Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaochun Zhang

Role: CONTACT

zhang.xiaochun1@zs-hospital.sh.cn

15002121366

Facility Contacts

Xiaochun Zhang

Role: primary

Other Identifiers

YL-2020-18

Identifier Type: -

Identifier Source: org_study_id