Trial | NCT01354808  Report issue

Title

ACCEL-LOADING-ACS Study
ACCELerated Inhibition of Platelet Aggregation, Inflammation and Ischemia-reperfusion Injury by Adjunctive Cilostazol Loading in Patients With Acute Coronary Syndrome

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    220
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).
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 Started
Jul 31
2010
Primary Completion
Jul 31
2012
Last Update
Sep 24
2013
Estimate

Drug Dual Anti-Platelet Therapy (DAPT)

Loading: aspirin 300mg + clopidogrel 600mg Maintenance: aspirin 200mg/d + clopidogrel 75mg/d for 1 month

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

DAPT Active Comparator

TAPT Experimental

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
No Results Posted