Cardiac Death, Cerebrovascular Accident, Hemorrhage, Myocardial Infarction
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of 5mg maintenance dose (MD) of prasugrel in patients with acute myocardial infarction (AMI) who underwent percutaneous coronary intervention (PCI) with BiomatrixTM stent.
Detailed description
About 1400 patients derived from Korean patients with acute coronary syndrome (ACS) receiving percutaneous coronary intervention (PCI) with BES(Biolimus-eluting stent, BiomatrixTM) in a routine manner will be enrolled in the investigators trial. These patients will be randomized 1:1 to either prasugrel 5mg once daily MD or clopidogrel 75mg once daily MD after successful PCI with BES . The investigators excluded the patients with age ≥75 years, body weight \<60 kg, or history of TIA (transient ischemic attack) or stroke. Follow-up data will be collected until 1-year after index procedure. Primary efficacy end-point defined as the composite of cardiac death, non-fatal MI, stent thrombosis and ischemic driven target vessel revascularization and safety end-points as BARC (the Bleeding Academic Research Consortium) type ≥ 2 bleeding.
Interventions
DEVICEBES (biodegradable polymer biolimus-eluting stent)
BES implantation
DRUGPrasugel
DRUGClopidogrel
Sponsors
Chonnam National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients who can undergo percutaneous coronary intervention with Biomatrix stent with no history of TIA or stroke, * 75 years old or younger, * body weight of 60 kg or more and diagnosed with acute coronary syndrome
Exclusion criteria
* Patients with history of TIA or stroke, * 75 years old or older, * body weight of 60 kg or under, * hypersensitivity to or contraindicated for heparin, aspirin, clopidogrel, prasugrel or contrast media
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A compoiste of cardiac death, non-fatal myocardiac infarction and stroke | within the 1 year after BIOMATRIXTM Stent implantation |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac death | within the 1 year after BIOMATRIXTM Stent implantation |
| non-fatal myocardial infarction | within the 1 year after BIOMATRIXTM Stent implantation |
| Stroke | within the 1 year after BIOMATRIXTM Stent implantation |
| All-cause death | within the 1 year after BIOMATRIXTM Stent implantation |
| stent thrombosis | within the 1 year after BIOMATRIXTM Stent implantation |
| BARC bleeding 2,3,and 5 | within the 1 year after BIOMATRIXTM Stent implantation |
| Target lesion revascularization | within the 1 year after BIOMATRIXTM Stent implantation |
Countries
South Korea
Contacts
Primary ContactMyung-Ho Jeong, PhD
Outcome results
None listed