ClinicalTrials.gg
Status unknownNCT04550637Updated Oct 18, 2022

A Multi-center Study of Apixaban(APPROACH)

An observational study in Evaluate the Safety and Efficacy of Apixaban, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-18.

Sponsored by Shanghai Zhongshan Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Evaluate the Safety and Efficacy of Apixaban
03

In context

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 648 studies on the registry; 289 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
24 Weeks
Patient registry
Yes

Groups and cohorts

  • Anticoagulant therapy after percutaneous left atrial appendage

    Oral apixaban

    Drug: Oral apixaban

Interventions

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

06

What researchers measure

Primary outcomes

  1. Incidence of adverse cardiovascular events

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

    Time frame: within 24 weeks after surgery

Secondary outcomes

  1. 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.

    Time frame: within 24 weeks after surgery

  2. Bleeding event

    Including dermal, mucosal, nasal, oral, gastrointestinal bleeding

    Time frame: within 24 weeks after surgery

  3. Incidence of deaths

    All cause deaths (cardiac death, and non cardiac death)

    Time frame: witnin 24 weeks after surgery

  4. Device related thrombosis

    Doctors find thrombosis after LAAC by transesophageal echocardiography.

    Time frame: 12 weeks and 24 weeks after surgery

  5. Incidence of cardiovascular disease-related rehospitalization

    Cardiovascular disease include pericardial effusion, pericardial tamponade, poor cardiac function

    Time frame: 12 weeks and 24 weeks after surgery

  6. severe adverse events

    Severe adverse events include re-inpatient for poor cardiac function and other severe adverse events.

    Time frame: 12 weeks and 24 weeks after surgery

07

Study locations

1 of 1 sites recruiting
  • Zhongshan Hospital
    Shanghai, China
    • Xiaochun Zhang · Contact
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2022 (actual). Primary completion is estimated for Dec 2023, 17 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 17, 2020
First posted
Sep 16, 2020
StartActual
Jul 4, 2022
Primary completionEst.
Dec 31, 2023
CompletionEst.
Dec 31, 2024
Last update
Oct 18, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04550637
Responsible party
Sponsor
First posted
Sep 16, 2020
Start date
Jul 4, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Oct 18, 2022

Study contacts

Xiaochun Zhang
Contact
zhang.xiaochun1@zs-hospital.sh.cn
15002121366
Junbo Ge
study chair · Fudan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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