ACCEL-LOADING-ACS Study

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Platelet Aggregation Inhibitors; Anti-inflammatory Agent; Myocardial Reperfusion Injury	Drug: Dual Anti-Platelet Therapy (DAPT); Drug: Triple Anti-Platelet Therapy (TAPT)	Phase 4

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	220 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	ACCELerated Inhibition of Platelet Aggregation, Inflammation and Ischemia-reperfusion Injury by Adjunctive Cilostazol Loading in Patients With Acute Coronary Syndrome
Study Start Date :	July 2010
Actual Primary Completion Date :	July 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: DAPT	Drug: Dual Anti-Platelet Therapy (DAPT); Loading: aspirin 300mg + clopidogrel 600mg; Maintenance: aspirin 200mg/d + clopidogrel 75mg/d for 1 month
Experimental: TAPT	Drug: Triple Anti-Platelet Therapy (TAPT); Loading: cilostazol 200mg + aspirin 300mg + clopidogrel 600mg; Maintenance: cilostazol 100mg bid+ aspirin 200mg/d+ clopidogrel 75mg/d for 1 month

Outcome Measures

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Primary Outcome Measures :

1. Major adverse cardiovascular events (MACE) [ Time Frame: 1 month ]
   Composite of cardiac death, MI and ischemia-driven target lesion revascularization (TLR)

Secondary Outcome Measures :

1. P2Y12 reaction unit levels in the 2 arms [ Time Frame: 1 month ]
2. MACE incidence according to P2Y12 reaction unit [ Time Frame: 1 month ]
3. any post-procedural increase of markers of myocardial injury above ULN [ Time Frame: 1 month ]
4. post-procedural variations from baseline of hs-CRP levels in the 2 arms [ Time Frame: 1 month ]
5. ACUITY major/minor bleeding rate [ Time Frame: 1 month ]
6. 24hr post-procedural variations from baseline of inflammation markers (IL-6, TNF-alpha, cell adhesion molecules (VCAM, ICAM, E-selectin) [ Time Frame: 1 month ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• at least 18 years of age
• Non-ST-elevation ACS patients undergoing PCI within 48 hours after hospitalization

Exclusion Criteria:

• ST segment elevation acute myocardial infarction
• NSTE ACS with high-risk features warranting emergency coronary angiography
• Oral anticoagulation therapy with warfarin
• Use of pre-procedural glycoprotein IIb/IIIa inhibitor
• Contraindication to antiplatelet therapy
• AST or ALT ≥ 3 times upper normal
• Left ventricular ejection fraction < 30%
• WBC < 3,000/mm3, platelet < 100,000/mm3
• Creatinine ≥ 3 mg/dl
• stroke within 3 months

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Korea, Republic of
Gyeonsang National University Hospital
Jinju, Gyeonsangnam-do, Korea, Republic of, 660-702

Sponsors and Collaborators

Gyeongsang National University Hospital

Investigators

Principal Investigator:	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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

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.

Responsible Party:	Gyeongsang National University Hospital
ClinicalTrials.gov Identifier:	NCT01354808 History of Changes
Other Study ID Numbers:	ACCEL-LOADING
First Posted:	May 17, 2011
Last Update Posted:	September 24, 2013
Last Verified:	September 2013

Keywords provided by Gyeongsang National University Hospital:

Cilostazol; Platelet; Inflammation; Myonecrosis

Additional relevant MeSH terms:

Reperfusion Injury; Myocardial Reperfusion Injury; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Cardiomyopathies; Heart Diseases; Myocardial Ischemia; Cilostazol; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents	Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Vasodilator Agents; Neuroprotective Agents; Protective Agents; Phosphodiesterase 3 Inhibitors; Phosphodiesterase Inhibitors; Enzyme Inhibitors