The Study to Evaluate the Safety and Efficacy of the Onyx Family
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age75-100
SponsorPusan National University Yangsan Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
Patients who underwent percutaneous coronary intervention using Onyx family stents in those aged 75 years or older
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Onyx family
DeviceSafety and Efficacy of 1-Month DAPT in Elderly Patients at High Risk of Ischemia and Bleeding After Percutaneous Coronary Intervention with Onyx Family Stents
Treatment groups
500 Participants
are divided into 5 treatment groupsGroup A: Aged 75 or more1 intervention
Group B: Eligible for interventional procedures1 intervention
Group C: Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%1 intervention
Group D: Able to take antiplatelets for at least 1 months after the procedure1 intervention
Group E: Patients who underwent coronary artery procedures with ZES stent1 intervention
Trial outcomes
Primary outcomes
1
MACCE at 12 months after coronary artery intervention
MACCE defined as a composite of all-cause mortality, MI, and cerebrovascular events at 12 months after the index procedure
Time frame
1 year after the procedureSecondary outcomes
1
safety of procedures
All-cause mortality
Time frame
1 year after the procedure2
safety of procedures
occurrence of Cardiac mortality
Time frame
1 year after the procedure3
safety of procedures
occurrence of myocardial infarction
Time frame
1 year after the procedure4
safety of procedures
occurrence of Cerebrovascular events
Time frame
1 year after the procedureSponsors and contacts
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Source ClinicalTrials.gov