A Multi-center Study of Apixaban(APPROACH)

Evaluate the Safety and Efficacy of Apixaban Clinical Trial

Official title:

A Multi-center Observative Study of Apixaban After Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04550637
• Other study ID #: YL-2020-18
• Status: Recruiting
• Start date: July 4, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Xiaochun Zhang
• Phone: 15002121366
• Email: zhang.xiaochun1[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Evaluate the Safety and Efficacy of Apixaban

Intervention

Drug:
• Oral apixaban
apixaban (5 mg bid) is given until 12 weeks after surgery

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse cardiovascular events	all cause death, stroke, transient ischemic attack, systemic embolism	within 24 weeks after surgery
Secondary	Hemorrhagic/ischemic stroke events	Stroke was defined as patients who developed dysarthria, aphasia, or weakness or sensory loss in the contralateral face, arm, or leg and cerebral ischemia and/or infarction. Diagnosis by clinical symptoms and cranial imaging examination.	within 24 weeks after surgery
Secondary	Bleeding event	Including dermal, mucosal, nasal, oral, gastrointestinal bleeding	within 24 weeks after surgery
Secondary	Incidence of deaths	All cause deaths (cardiac death, and non cardiac death)	witnin 24 weeks after surgery
Secondary	Device related thrombosis	Doctors find thrombosis after LAAC by transesophageal echocardiography.	12 weeks and 24 weeks after surgery
Secondary	Incidence of cardiovascular disease-related rehospitalization	Cardiovascular disease include pericardial effusion, pericardial tamponade, poor cardiac function	12 weeks and 24 weeks after surgery
Secondary	severe adverse events	Severe adverse events include re-inpatient for poor cardiac function and other severe adverse events.	12 weeks and 24 weeks after surgery