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ACCEL-LOADING-ACS Study

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ClinicalTrials.gov Identifier: NCT01354808
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : September 24, 2013
Sponsor:
Information provided by (Responsible Party):
Gyeongsang National University Hospital

Study Description
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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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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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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354808


Locations
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Korea, Republic of
Gyeonsang National University Hospital
Jinju, Gyeonsangnam-do, Korea, Republic of, 660-702
Sponsors and Collaborators
Gyeongsang National University Hospital
Investigators
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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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Publications of Results:

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Responsible Party: Gyeongsang National University Hospital
ClinicalTrials.gov Identifier: NCT01354808    
Other Study ID Numbers: ACCEL-LOADING
First Posted: May 17, 2011    Key Record Dates
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:
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Reperfusion Injury
Myocardial Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
 Pathologic Processes
Cardiomyopathies
Heart Diseases
Myocardial Ischemia