ACCEL-LOADING-ACS Study
Primary Purpose
Platelet Aggregation Inhibitors, Anti-inflammatory Agent, Myocardial Reperfusion Injury
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dual Anti-Platelet Therapy (DAPT)
Triple Anti-Platelet Therapy (TAPT)
Sponsored by
About this trial
This is an interventional treatment trial for Platelet Aggregation Inhibitors focused on measuring Cilostazol, Platelet, Inflammation, Myonecrosis
Eligibility 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
Sites / Locations
- Gyeonsang National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
DAPT
TAPT
Arm Description
Outcomes
Primary Outcome Measures
Major adverse cardiovascular events (MACE)
Composite of cardiac death, MI and ischemia-driven target lesion revascularization (TLR)
Secondary Outcome Measures
P2Y12 reaction unit levels in the 2 arms
MACE incidence according to P2Y12 reaction unit
any post-procedural increase of markers of myocardial injury above ULN
post-procedural variations from baseline of hs-CRP levels in the 2 arms
ACUITY major/minor bleeding rate
24hr post-procedural variations from baseline of inflammation markers (IL-6, TNF-alpha, cell adhesion molecules (VCAM, ICAM, E-selectin)
Full Information
NCT ID
NCT01354808
First Posted
May 15, 2011
Last Updated
September 23, 2013
Sponsor
Gyeongsang National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01354808
Brief Title
ACCEL-LOADING-ACS Study
Official Title
ACCELerated Inhibition of Platelet Aggregation, Inflammation and Ischemia-reperfusion Injury by Adjunctive Cilostazol Loading in Patients With Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gyeongsang National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet Aggregation Inhibitors, Anti-inflammatory Agent, Myocardial Reperfusion Injury
Keywords
Cilostazol, Platelet, Inflammation, Myonecrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DAPT
Arm Type
Active Comparator
Arm Title
TAPT
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dual Anti-Platelet Therapy (DAPT)
Intervention Description
Loading: aspirin 300mg + clopidogrel 600mg
Maintenance: aspirin 200mg/d + clopidogrel 75mg/d for 1 month
Intervention Type
Drug
Intervention Name(s)
Triple Anti-Platelet Therapy (TAPT)
Intervention Description
Loading: cilostazol 200mg + aspirin 300mg + clopidogrel 600mg
Maintenance: cilostazol 100mg bid+ aspirin 200mg/d+ clopidogrel 75mg/d for 1 month
Primary Outcome Measure Information:
Title
Major adverse cardiovascular events (MACE)
Description
Composite of cardiac death, MI and ischemia-driven target lesion revascularization (TLR)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
P2Y12 reaction unit levels in the 2 arms
Time Frame
1 month
Title
MACE incidence according to P2Y12 reaction unit
Time Frame
1 month
Title
any post-procedural increase of markers of myocardial injury above ULN
Time Frame
1 month
Title
post-procedural variations from baseline of hs-CRP levels in the 2 arms
Time Frame
1 month
Title
ACUITY major/minor bleeding rate
Time Frame
1 month
Title
24hr post-procedural variations from baseline of inflammation markers (IL-6, TNF-alpha, cell adhesion molecules (VCAM, ICAM, E-selectin)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyounghoon Lee, MD, PhD
Organizational Affiliation
Gil hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae-Hyeong Park, MD, PhD
Organizational Affiliation
Chungnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keun-Ho Park, MD
Organizational Affiliation
Heart Center of Chonnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jon Suh, MD, PhD
Organizational Affiliation
Soon Chun Hyang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang-Yong Yoo, MD, PhD
Organizational Affiliation
Gangneung Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gyeonsang National University Hospital
City
Jinju
State/Province
Gyeonsangnam-do
ZIP/Postal Code
660-702
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
17394957
Citation
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.
Results Reference
result
PubMed Identifier
20118150
Citation
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.
Results Reference
result
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ACCEL-LOADING-ACS Study
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