ACCEL-LOADING-ACS Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gyeongsang National University Hospital
ClinicalTrials.gov Identifier:
NCT01354808
First received: May 15, 2011
Last updated: September 23, 2013
Last verified: September 2013
  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:


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:
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:
Inflammation
Myocardial Reperfusion Injury
Reperfusion Injury
Acute Coronary Syndrome
Wounds and Injuries
Pathologic Processes
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Postoperative Complications
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Cilostazol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents

ClinicalTrials.gov processed this record on August 28, 2014