LAAO With DAPT Versus Antithrombotic Therapy

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310801
• Other study ID #: LAAO with DAPT
• Status: Completed
• Phase: N/A
• First received: September 17, 2017
• Last updated: October 10, 2017
• Start date: August 1, 2016
• Est. completion date: August 30, 2017

Study information

• Verified date: October 2017
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: August 30, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• ACP or Watchman
Left atrial appnedage occlusion using ACP or Watchman

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Korea University Anam Hospital	Gachon University Gil Medical Center, Sejong General Hospital, Severance Hospital, Ulsan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of stroke and major bleeding	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