Safety and Efficacy of 1-month Dual Antiplatelet Therapy in High Bleeding and Ischemic Risk Elderly Patients With Coronary Artery Disease After Implantation of Zotarolimus-eluting Coronary Stent System (Onyx Family, Medtronic, Minneapolis, MN); A Multicenter, Prospective, Observational Study

Pusan National University Yangsan Hospital1 site in 1 country500 target enrollmentJune 9, 2022

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Pusan National University Yangsan Hospital
Enrollment: 500
Locations: 1
Primary Endpoint: MACCE at 12 months after coronary artery intervention
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Observation of the safety and efficacy of 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention using Onyx family stents in elderly patients aged 75 years or older

Detailed Description

For elderly patients aged 75 years or older undergoing percutaneous coronary intervention with Onyx family drug-eluting stents, observe the safety and efficacy of transitioning from dual antiplatelet therapy to single therapy for one year after one month of dual antiplatelet therapy

Registry

clinicaltrials.gov

Start Date

June 9, 2022

End Date

December 31, 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Pusan National University Yangsan Hospital

Responsible Party

Principal Investigator

Min Ku Chon

Associate Professor

Pusan National University Yangsan Hospital

Eligibility Criteria

Inclusion Criteria

•Aged 75 or more.
•Eligible for interventional procedures.
•Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%.
•Able to take antiplatelets for at least 1 months after the procedure.
•Patients who underwent coronary artery procedures with ZES (Medtronic, Minneapolis, MN, Onyx™ family) stent.

Exclusion Criteria

•The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, zotarolimus, and contrast media (patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine \[eg, rash\] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled).
•Patients with active pathologic bleeding.
•Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
•History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia).
•Noncardiac comorbid conditions are present with life expectancy \<1 year or that may result in protocol noncompliance (per site investigator's medical judgment).
•Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.