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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BES with Prasugel 5mg | Active Comparator | Biolimus-eluting stent with Prasugrel 5mg once daily MD |
|
| BES with Clopidogrel 75mg | Active Comparator | Biolimus-eluting stent with Clopidogrel 75mg once daily MD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BES (biodegradable polymer biolimus-eluting stent) | Device | BES implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| A compoiste of cardiac death, non-fatal myocardiac infarction and stroke | within the 1 year after BIOMATRIXTM Stent implantation |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | within the 1 year after BIOMATRIXTM Stent implantation | |
| Cardiac death | within the 1 year after BIOMATRIXTM Stent implantation | |
| non-fatal myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myung-Ho Jeong, PhD | Contact | +82-062-220-5114 |
| Name | Affiliation | Role |
|---|---|---|
| Myung Ho Jeong, PhD | Chonnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jung-Me Lee | Recruiting | Pusan | South Korea |
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| Prasugel | Drug |
|
| Clopidogrel | Drug |
|
| within the 1 year after BIOMATRIXTM Stent implantation |
| Stroke | within the 1 year after BIOMATRIXTM Stent implantation |
| Target lesion revascularization | 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 |
| ID | Term |
|---|---|
| D003643 | Death |
| D006470 | Hemorrhage |
| D020521 | Stroke |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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