ACCEL-LOADING-ACS Study - Full Text View

Purpose

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	Intervention	Phase
Platelet Aggregation Inhibitors Anti-inflammatory Agent Myocardial Reperfusion Injury	Drug: Dual Anti-Platelet Therapy (DAPT) Drug: Triple Anti-Platelet Therapy (TAPT)	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Cilostazol

U.S. FDA Resources

Further study details as provided by Gyeongsang National University Hospital:

Primary Outcome Measures:

Major adverse cardiovascular events (MACE) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Composite of cardiac death, MI and ischemia-driven target lesion revascularization (TLR)

Secondary Outcome Measures:

P2Y12 reaction unit levels in the 2 arms [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
MACE incidence according to P2Y12 reaction unit [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
any post-procedural increase of markers of myocardial injury above ULN [ Time Frame: 1 month ] [ Designated as safety issue: No ]
post-procedural variations from baseline of hs-CRP levels in the 2 arms [ Time Frame: 1 month ] [ Designated as safety issue: No ]
ACUITY major/minor bleeding rate [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
24hr post-procedural variations from baseline of inflammation markers (IL-6, TNF-alpha, cell adhesion molecules (VCAM, ICAM, E-selectin) [ Time Frame: 1 month ] [ Designated as safety issue: No ]


Estimated Enrollment:	220
Study Start Date:	July 2010
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354808

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

Publications:

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
Study First Received:	May 15, 2011
Last Updated:	September 23, 2013
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Gyeongsang National University Hospital:


Cilostazol Platelet Inflammation Myonecrosis

Additional relevant MeSH terms:


Myocardial Reperfusion Injury Reperfusion Injury Cardiomyopathies Cardiovascular Diseases Heart Diseases	Myocardial Ischemia Pathologic Processes Postoperative Complications Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015