A Multi-center Study of Apixaban(APPROACH)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Incidence of adverse cardiovascular events [within 24 weeks after surgery]
all cause death, stroke, transient ischemic attack, systemic embolism
Secondary Outcome Measures
- 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.
- Bleeding event [within 24 weeks after surgery]
Including dermal, mucosal, nasal, oral, gastrointestinal bleeding
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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age between 18 to 85 years;
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understand the purpose of the trial, sign the informed consent form voluntarily
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successful surgery (no pericardial effusion, pericardial tamponade, or device displacement during operation; no pericardial effusion before discharge), meet COST standard during operation.
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In accordance with the indications for left atrial appendage occlusion: CHA2DS2-VAS2 score≥2 points and/or HAS-BLED score≥3 points
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unable or unwilling to take oral anticoagulants
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life expectancy≥1 year
Exclusion Criteria:
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History of previous cardiac surgery (valve disease, cardiomyopathy, severe coronary occlusion);
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Inability to tolerate trans-esophageal echocardiography;
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Preoperative trans-esophageal echocardiography suggests thrombus in left atrial appendage/left atrial;
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Patients with severe renal insufficiency (creatinine clearance rate<15ml/min);
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Patients with liver disease accompanied by abnormal blood coagulation and clinically related bleeding risks;
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Clinically significant active bleeding;
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The baseline platelet count is severely reduced: PLT≤50*10^9/L;
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Severe cardiac insufficiency (preoperative transthoracic echocardiography indicated LVEF <35%; uncontrolled heart failure (NYHA IV))
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Allergy or contraindication to anticoagulant drugs such as aspirin, clopidogrel, apixaban, etc .;
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Serious heart valve disease or other structural abnormalities need do elective surgical treatment; or severe coronary heart disease require limited-term intervention;
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Less than 45kg or more than 100kg.
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Take strong CYP3A4 and P-gp inhibitors (including pyrrole antifungal drugs, HIV protease inhibitors, etc.) for systemic treatment;
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Patients with other diseases besides atrial fibrillation (such as after mechanical valve replacement, spontaneous or recurrent venous thromboembolism, etc.) need anticoagulation treatment;
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Unsuccessful surgery (serious pericardial tamponade, massive bleeding and other life-threatening complications occur within 3 days after left atrial appendage closure);
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Pregnancy or lactation;
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Participating in other uncompleted clinical trials;
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Investigator considers inappropriate subjects.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Hospital | Shanghai | China |
Sponsors and Collaborators
- Shanghai Zhongshan Hospital
Investigators
- Study Chair: Junbo Ge, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YL-2020-18