ACCEL-LOADING-ACS Study

Phase 4

Completed

• Conditions: Platelet Aggregation Inhibitors; Anti-inflammatory Agent; Myocardial Reperfusion Injury
• Interventions: Drug: Dual Anti-Platelet Therapy (DAPT); Drug: Triple Anti-Platelet Therapy (TAPT)

• Registration Number: NCT01354808
• Lead Sponsor: Gyeongsang National University Hospital

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-05-15
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-17
• Primary Completion: 2012-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-23
• Last Update Posted: 2013-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAPT	Dual Anti-Platelet Therapy (DAPT)	-
TAPT	Triple Anti-Platelet Therapy (TAPT)	-

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events (MACE)	1 month	Composite of cardiac death, MI and ischemia-driven target lesion revascularization (TLR)

Secondary Outcome Measures

Name	Time	Method
P2Y12 reaction unit levels in the 2 arms	1 month
24hr post-procedural variations from baseline of inflammation markers (IL-6, TNF-alpha, cell adhesion molecules (VCAM, ICAM, E-selectin)	1 month
MACE incidence according to P2Y12 reaction unit	1 month
post-procedural variations from baseline of hs-CRP levels in the 2 arms	1 month
ACUITY major/minor bleeding rate	1 month
any post-procedural increase of markers of myocardial injury above ULN	1 month

Trial Locations

Locations (1)

Gyeonsang National University Hospital; 🇰🇷 Jinju, Gyeonsangnam-do, Korea, Republic of