A Phase 4 interventional study of antiplatelet therapy in Acute Myocardial Infarction, sponsored by Korea University Guro Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by Korea University Guro Hospital · Phase 4, Interventional, and Treatment
Current antiplatelet therapy in acute coronary syndrome have a focus on the dual antiplatelet therapy including aspirin and clopidogrel. However, the patient's drug resistance of aspirin and clopidogrel is the important cause of poor clinical prognosis. Therefore, recently, clinical research about the triple antiplatelet therapy including cilostazol is actively conducted. But, clinical research about triple antiplatelet therapy for acute myocardial infarction is inadequate situation, and the ideal duration of triple antiplatelet therapy has been actively discussed. Therefore, we try to evaluate the clinical outcomes of triple antiplatelet therapy in acute myocardial infarction patients undergoing percutaneous intervention with drug eluting stent compared with dual antiplatelet therapy and investigate ideal duration of triple antiplatelet therapy through this research.
Drug-eluting stents (DES) have drastically changed the landscape of percutaneous coronary intervention (PCI), with significant reductions in the angiographic restenosis rate and need for repeated revascularization. However, several studies showed that DES is associated with a higher incidence of in-stent thrombosis compared with bare metal stents. Therefore, the latest guideline for antiplatelet therapy after PCI with DES suggests that the dual antiplatelet therapy (aspirin plus clopidogrel) be administered for at least 12 months.But is it enough for high-risk patients? Some studies showed that as many as 50% of the patients who received PCI did not react positively to aspirin or clopidogrel.Furthermore, there is increased platelet activity in acute coronary syndrome, especially in acute myocardial infarction (AMI). compared with aspirin or clopidogrel.A recent study suggested that cilostazol could ameliorate platelet responsiveness to clopidogrel in patients who underwent primary PCI. Furthermore, some other studies showed that the administration of cilostazol after PCI could significantly lower the incidence of in-stent restenosis. Therefore, the present study is designed to evaluate the safety and efficacy of additional administration of cilostazol with aspirin and clopidogrel in a real-world cardiology practice among patients presenting with AMI who received primary PCI with DES.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's planned enrollment of 951 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Korea University Guro Hospital is the lead sponsor of 83 studies on the registry; 15 are open to participants now.
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Inclusion Criteria: Acute Myocardial Infarction Undergoing Primary percutaneous coronary intervention.
Exclusion Criteria:
Dual antiplatelet therapy for 1 year : dual antiplatelet combination therapy with aspirin and clopidogrel for 1 year
Drug: antiplatelet therapy
Triple antiplatelet therapy for 1 month : triple antiplatelet therapy including cilostazol for 1 month and after then, dual antiplatelet therapy for 11 months
Drug: antiplatelet therapy
Triple antiplatelet therapy for 6 months : triple antiplatelet combination therapy including cilostazol for 6 months and after then, dual antiplatelet therapy for 6 months and cilostazol
Drug: antiplatelet therapy
Dual antiplatelet therapy is defined as combination therapy with aspirin and clopidogrel and triple antiplatelet therapy is defined as combination therapy with aspirin,clopidogrel and cilostazol.
Also known as: The brand name of clopidogrel is Plavix., The brand name of cilostazol is Pletaal.
Major Adverse Cardiovascular and Cerebral Events
Composite of total death, Nonfatal Myocardial Infarction (Non-QMI , Q-MI), Repeat RevascularizationI (Target Vessel Revascularization +Non Target Vessel Revascularization , Coronary Artery Bypass Graft), Stroke (Ischemic \& Hemorrhagic)
Time frame: One Year
Individual outcome of primary end points, Stent thrombosis,Bleeding Complication,PFT (Platelet function test),Genotyping results
1. Individual outcome of primary end points 2. Stent thrombosis 3. Beeding Complication defined by the TIMI criteria \& Minor Bleeding, Vascular Complications 4. Angiographic outcomes at 1 year : Binary restenosis, Late loss, FU MLD, mean % restenosis, restenosis type 5. IVUS findings at Index and Follow up angiography 6. PFT (Platelet function test) : at discharge, intercurrent event , after one year 7. Genotyping results : genetic polymorphism
Time frame: One year
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Korea University Guro Hospital