A Multi-center Study of Apixaban(APPROACH)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    200
  • sponsor
    Shanghai Zhongshan Hospital
Updated on 25 January 2021

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.

Details
Condition Evaluate the Safety and Efficacy of Apixaban
Treatment Oral apixaban
Clinical Study IdentifierNCT04550637
SponsorShanghai Zhongshan Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 85 yrs?
Gender: Male or Female
Do you have Evaluate the Safety and Efficacy of Apixaban?
Do you have any of these conditions: Do you have Evaluate the Safety and Efficacy of Apixaban??
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 score2 points and/or HAS-BLED score3 points
unable or unwilling to take oral anticoagulants
life expectancy1 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: PLT5010^9/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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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