A Multi-center Study of Apixaban(APPROACH)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Evaluate the Safety and Efficacy of Apixaban
• Intervention / Treatment: Drug: Oral apixaban

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Xiaochun Zhang; Phone Number: 15002121366; Email: zhang.xiaochun1@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study is going to enroll approximately 200 cases who completed left atrial appendage occlusion (LAAO) successfully from 10 research centers nationwide.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anticoagulant therapy after percutaneous left atrial appendage; Oral apixaban	Drug: Oral apixaban; apixaban (5 mg bid) is given until 12 weeks after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse cardiovascular events	all cause death, stroke, transient ischemic attack, systemic embolism	within 24 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Bleeding event	Including dermal, mucosal, nasal, oral, gastrointestinal bleeding	within 24 weeks after surgery
Incidence of deaths	All cause deaths (cardiac death, and non cardiac death)	witnin 24 weeks after surgery
Device related thrombosis	Doctors find thrombosis after LAAC by transesophageal echocardiography.	12 weeks and 24 weeks after surgery
Incidence of cardiovascular disease-related rehospitalization	Cardiovascular disease include pericardial effusion, pericardial tamponade, poor cardiac function	12 weeks and 24 weeks after surgery
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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Junbo Ge, Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 4, 2022
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: May 17, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (ACTUAL): September 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 16, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Apixaban
• Other Study ID Numbers: YL-2020-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No