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ACCEL-LOADING-ACS Study

Information source: Gyeongsang National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Platelet Aggregation Inhibitors; Anti-inflammatory Agent; Myocardial Reperfusion Injury

Intervention: Dual Anti-Platelet Therapy (DAPT) (Drug); Triple Anti-Platelet Therapy (TAPT) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Gyeongsang National University Hospital

Official(s) and/or principal investigator(s):
Kyounghoon Lee, MD, PhD, Principal Investigator, Affiliation: Gil hospital
Jae-Hyeong Park, MD, PhD, Principal Investigator, Affiliation: Chungnam National University Hospital
Keun-Ho Park, MD, Principal Investigator, Affiliation: Heart Center of Chonnam National University Hospital
Jon Suh, MD, PhD, Principal Investigator, Affiliation: Soon Chun Hyang University
Sang-Yong Yoo, MD, PhD, Principal Investigator, Affiliation: Gangneung Asan Medical Center

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).

Clinical Details

Official title: ACCELerated Inhibition of Platelet Aggregation, Inflammation and Ischemia-reperfusion Injury by Adjunctive Cilostazol Loading in Patients With Acute Coronary Syndrome

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Major adverse cardiovascular events (MACE)

Secondary outcome:

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)

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Gyeonsang National University Hospital, Jinju, Gyeonsangnam-do 660-702, Korea, Republic of
Additional Information

Starting date: July 2010
Last updated: September 23, 2013

Page last updated: August 23, 2015

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