LAAO With DAPT Versus Antithrombotic Therapy

October 10, 2017 updated by: Dr. Cheol Woong Yu, Korea University Anam Hospital

Comparison of Clinical Outcomes Between Left Atrial Appendage Occlusion With Dual Antiplatelet Therapy Versus Conventional Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Drug-eluting Stent Implantation

This study will retrospectively review and compare clinical outcomes between left atrial appendage occlusion with dual antiplatelet therapy versus conventional antithrombotic therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Composite of stroke and major bleeding will be compared after adjusting those groups using inverse probability weighted model.

Study Type

Observational

Enrollment (Actual)

480

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with AF who underwent PCI

Description

Inclusion Criteria:

  • patients with AF who underwent PCI and treated with LAAO and DAPT or conventional antithrombotic therapy

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LAAO with DAPT
patients with AF who underwent PCI and treated with LAAO(either ACP or Watchman) and DAPT
Procedure: ACP or Watchman
Left atrial appnedage occlusion using ACP or Watchman
Conventional antithrombotic therapy
patients with AF who underwent PCI and treated with conventional antithrombotic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of stroke and major bleeding
Time Frame: From date of index procedure until the date of primary endpoint occur or date of last follow up, whichever came first, assessed up to 50 months
Primary endpoint is a composite of stroke and major bleeding. Stroke is defined as ischemic cerebrovascular event included both transient ischemic attack and ischemic cerebral infarction. Major bleeding event was defined as moderate or severe bleeding according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries criteria.
From date of index procedure until the date of primary endpoint occur or date of last follow up, whichever came first, assessed up to 50 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Collaborators

Ulsan University Hospital
Gachon University Gil Medical Center
Severance Hospital
Sejong General Hospital

Investigators

  • Principal Investigator: Cheol Woong Yu, MD, PhD, Korea University Anam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 30, 2017

Study Registration Dates

First Submitted

September 17, 2017

First Submitted That Met QC Criteria

October 10, 2017

First Posted (Actual)

October 16, 2017

Study Record Updates

Last Update Posted (Actual)

October 16, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAAO with DAPT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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