A Multi-center Study of Apixaban(APPROACH)

Recruiting

• Conditions: Evaluate the Safety and Efficacy of Apixaban
• Interventions: Drug: Oral apixaban

• Registration Number: NCT04550637
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-17
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-16
• Study Start: 2022-07-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-16
• Last Update Posted: 2022-10-18
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anticoagulant therapy after percutaneous left atrial appendage	Oral apixaban	Oral apixaban

Primary Outcome Measures

Name	Time	Method
Incidence of adverse cardiovascular events	within 24 weeks after surgery	all cause death, stroke, transient ischemic attack, systemic embolism

Secondary Outcome Measures

Name	Time	Method
Bleeding event	within 24 weeks after surgery	Including dermal, mucosal, nasal, oral, gastrointestinal bleeding
Hemorrhagic/ischemic stroke events	within 24 weeks after surgery	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.
Incidence of deaths	witnin 24 weeks after surgery	All cause deaths (cardiac death, and non cardiac death)
Device related thrombosis	12 weeks and 24 weeks after surgery	Doctors find thrombosis after LAAC by transesophageal echocardiography.
Incidence of cardiovascular disease-related rehospitalization	12 weeks and 24 weeks after surgery	Cardiovascular disease include pericardial effusion, pericardial tamponade, poor cardiac function
severe adverse events	12 weeks and 24 weeks after surgery	Severe adverse events include re-inpatient for poor cardiac function and other severe adverse events.

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, China