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The purpose of this study is to determine whether adjunctive cilostazol loading/maintenance to standard treatment (aspirin, clopidogrel, and statin) is effective in reduction of major adverse cardiovascular events, platelet activation, inflammation and myonecrosis in patients with non-ST-elevation acute coronary syndrome (ACS)undergoing percutaneous coronary intervention (PCI).
In ACS patients, platelet activation, inflammation, and ischemia-reperfusion injury can be closely associated with the risk of post-PCI myonecrosis and ischemic events occurrence. In the ACCEL-AMI (Adjunctive Cilostazol versus high maintenance-dose ClopidogrEL in patients with Acute Myocardial Infarction)study, adjunctive cilostazol increased platelet inhibition compared with double-dose clopidogrel. Meanwhile, statins can reduce the extent of myonecrosis via limiting inflammation and myocardial infarct size by activating phosphatidylinositol-3-kinase (PI3K), ecto-5'-nucleotidase, Akt/endothelial nitric oxide synthase (eNOS), and the downstream effectors inducible nitric oxide synthase (iNOS) and cyclooxygenase-2 (COX-2). Inhibition of PI3K, adenosine receptors, eNOS, iNOS, or COX-2 abrogates the protective effects of statins. In animal study, the combination of low-dose statin with cilostazol synergistically limits infarct size. Multiple studies have shown that cilostazol can influence inflammation and RISK pathway using the similar pathway with statin. This study will be performed to evaluate the role of adjunctive cilostazol in platelet inhibition, inflammation, and myonecrosis compared with standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAPT | Active Comparator |
| |
| TAPT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual Anti-Platelet Therapy (DAPT) | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events (MACE) | Composite of cardiac death, MI and ischemia-driven target lesion revascularization (TLR) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| P2Y12 reaction unit levels in the 2 arms | 1 month | |
| MACE incidence according to P2Y12 reaction unit | 1 month | |
| any post-procedural increase of markers of myocardial injury above ULN |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyounghoon Lee, MD, PhD | Gil hospital | Principal Investigator |
| Jae-Hyeong Park, MD, PhD | Chungnam National University Hospital | Principal Investigator |
| Keun-Ho Park, MD | Heart Center of Chonnam National University Hospital | Principal Investigator |
| Jon Suh, MD, PhD | Soon Chun Hyang University | Principal Investigator |
| Sang-Yong Yoo, MD, PhD | Gangneung Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gyeonsang National University Hospital | Jinju | Gyeonsangnam-do | 660-702 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17394957 | Result | Patti G, Pasceri V, Colonna G, Miglionico M, Fischetti D, Sardella G, Montinaro A, Di Sciascio G. Atorvastatin pretreatment improves outcomes in patients with acute coronary syndromes undergoing early percutaneous coronary intervention: results of the ARMYDA-ACS randomized trial. J Am Coll Cardiol. 2007 Mar 27;49(12):1272-8. doi: 10.1016/j.jacc.2007.02.025. | |
| 20118150 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 18, 2020 | |
| Reset | Sep 3, 2020 | |
| Release | Jan 28, 2021 | |
| Reset | Feb 16, 2021 | |
| Release | Mar 15, 2022 | |
| Reset | Jun 27, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 18, 2020 | Sep 3, 2020 | |||
| Jan 28, 2021 |
| ID | Term |
|---|---|
| D015428 | Myocardial Reperfusion Injury |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| D000080903 | Dual Anti-Platelet Therapy |
| ID | Term |
|---|---|
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Triple Anti-Platelet Therapy (TAPT) | Drug |
|
|
| 1 month |
| post-procedural variations from baseline of hs-CRP levels in the 2 arms | 1 month |
| ACUITY major/minor bleeding rate | 1 month |
| 24hr post-procedural variations from baseline of inflammation markers (IL-6, TNF-alpha, cell adhesion molecules (VCAM, ICAM, E-selectin) | 1 month |
| Jeong YH, Hwang JY, Kim IS, Park Y, Hwang SJ, Lee SW, Kwak CH, Park SW. Adding cilostazol to dual antiplatelet therapy achieves greater platelet inhibition than high maintenance dose clopidogrel in patients with acute myocardial infarction: Results of the adjunctive cilostazol versus high maintenance dose clopidogrel in patients with AMI (ACCEL-AMI) study. Circ Cardiovasc Interv. 2010 Feb 1;3(1):17-26. doi: 10.1161/CIRCINTERVENTIONS.109.880179. Epub 2010 Jan 26. |
| Feb 16, 2021 |
| Mar 15, 2022 | Jun 27, 2022 |
| D014652 |
| Vascular Diseases |
| D015427 | Reperfusion Injury |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |