Evaluate the Safety and Efficacy of ApixabanNCT04550637
A Multi-center Study of Apixaban(APPROACH)
An observational study of Evaluate the Safety and Efficacy of Apixaban, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluate the Safety and Efficacy of Apixaban
- What is being tested?
- Oral apixaban
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2022to 31 Dec 2024
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study is going to enroll approximately 200 cases who completed left atrial appendage occlusion (LAAO) successfully from 10 research centers nationwide.
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Oral apixaban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral apixabanDrug
apixaban (5 mg bid) is given until 12 weeks after surgery
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulant therapy after percutaneous left atrial appendage | Oral apixaban Receives: Drug: Oral apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse cardiovascular events
all cause death, stroke, transient ischemic attack, systemic embolism
Measured: within 24 weeks after surgery
Secondary outcomes (6)
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.
Measured: within 24 weeks after surgery
Bleeding event
Including dermal, mucosal, nasal, oral, gastrointestinal bleeding
Measured: within 24 weeks after surgery
Incidence of deaths
All cause deaths (cardiac death, and non cardiac death)
Measured: witnin 24 weeks after surgery
Device related thrombosis
Doctors find thrombosis after LAAC by transesophageal echocardiography.
Measured: 12 weeks and 24 weeks after surgery
Incidence of cardiovascular disease-related rehospitalization
Cardiovascular disease include pericardial effusion, pericardial tamponade, poor cardiac function
Measured: 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.
Measured: 12 weeks and 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start4 Jul 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate the Safety and Efficacy of ApixabanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550637
- Sponsor's protocol ID
- YL-2020-18
- Status last verified
- Oct 2022
- First submitted
- 17 May 2020
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Observative Study of Apixaban After Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04550637
- Acronym / sponsor ID
- YL-2020-18
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anticoagulant therapy after percutaneous left atrial appendage | – | Drug: Oral apixabanOral apixaban |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study is going to enroll approximately 200 cases who completed left atrial appendage occlusion (LAAO) successfully from 10 research centers nationwide.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral apixabanapixaban (5 mg bid) is given until 12 weeks after surgery | Drug | Anticoagulant therapy after percutaneous left atrial appendage |
Primary outcome
Incidence of adverse cardiovascular events
Time frame: within 24 weeks after surgery
all cause death, stroke, transient ischemic attack, systemic embolism
6 secondary outcomes
Hemorrhagic/ischemic stroke events
Time frame: within 24 weeks after surgery
Bleeding event
Time frame: within 24 weeks after surgery
Incidence of deaths
Time frame: witnin 24 weeks after surgery
Device related thrombosis
Time frame: 12 weeks and 24 weeks after surgery
Incidence of cardiovascular disease-related rehospitalization
Time frame: 12 weeks and 24 weeks after surgery
severe adverse events
Time frame: 12 weeks and 24 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junbo Ge study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluate the Safety and Efficacy of Apixaban, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaochun Zhang (15002121366, zhang.xiaochun1@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse cardiovascular events (time frame: within 24 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022; AzTrials last refreshed its copy on 1 Nov 2026.