A Multi-center Study of Apixaban(APPROACH)

NCT04550637 | Unknown DMC FDA Drug

• 1 other identifier: YL-2020-18
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse cardiovascular events

  all cause death, stroke, transient ischemic attack, systemic embolism

  within 24 weeks after surgery

Secondary Outcomes (6)

• Hemorrhagic/ischemic stroke events

  within 24 weeks after surgery

• Bleeding event

  within 24 weeks after surgery

• Incidence of deaths

  witnin 24 weeks after surgery

• Device related thrombosis

  12 weeks and 24 weeks after surgery

• Incidence of cardiovascular disease-related rehospitalization

  12 weeks and 24 weeks after surgery

Study Arms (1)

Anticoagulant therapy after percutaneous left atrial appendage

Oral apixaban

Drug: Oral apixaban

Interventions

Oral apixaban DRUG

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

Anticoagulant therapy after percutaneous left atrial appendage

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

apixaban

Study Officials

• Junbo Ge

  Fudan University

  STUDY CHAIR

Central Study Contacts

Xiaochun Zhang

CONTACT

15002121366; zhang.xiaochun1@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2020
• First Posted: September 16, 2020
• Study Start: July 4, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

CN (1)