NCT01261832

Efficacy and Safety of Adjunctive Cilostazol in Acute Myocardial Infarction Patients

Randomized, Prospective , Open Label, Phase 4 Trial of Efficacy and Safety of Adjunctive Cilostazol in Acute Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention With Drug-eluting Stent

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 951 (estimated)
• Sponsor: Korea University Guro Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2020-02-01
• Completion: 2022-03-01
• First posted: 2010-12-17
• Last updated: 2020-02-20

Locations

1 site across 1 country: South Korea