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ACCEL-LOADING-ACS Study

NCT ID: NCT01354808

Last Updated: 2013-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Platelet Aggregation Inhibitors Anti-inflammatory Agent Myocardial Reperfusion Injury

Keywords

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Cilostazol Platelet Inflammation Myonecrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DAPT

Group Type ACTIVE_COMPARATOR

Dual Anti-Platelet Therapy (DAPT)

Intervention Type DRUG

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

TAPT

Group Type EXPERIMENTAL

Triple Anti-Platelet Therapy (TAPT)

Intervention Type DRUG

* Loading: cilostazol 200mg + aspirin 300mg + clopidogrel 600mg
* Maintenance: cilostazol 100mg bid+ aspirin 200mg/d+ clopidogrel 75mg/d for 1 month

Interventions

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Dual Anti-Platelet Therapy (DAPT)

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gyeongsang National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyounghoon Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gil hospital

Jae-Hyeong Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital

Keun-Ho Park, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center of Chonnam National University Hospital

Jon Suh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Soon Chun Hyang University

Sang-Yong Yoo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gangneung Asan Medical Center

Locations

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Gyeonsang National University Hospital

Jinju, Gyeonsangnam-do, South Korea

Site Status

Countries

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South Korea

References

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Patti G, Pasceri V, Colonna G, Miglionico M, Fischetti D, Sardella G, Montinaro A, Di Sciascio G. Atorvastatin pretreatment improves outcomes in patients with acute coronary syndromes undergoing early percutaneous coronary intervention: results of the ARMYDA-ACS randomized trial. J Am Coll Cardiol. 2007 Mar 27;49(12):1272-8. doi: 10.1016/j.jacc.2007.02.025.

Reference Type RESULT
PMID: 17394957 (View on PubMed)

Jeong YH, Hwang JY, Kim IS, Park Y, Hwang SJ, Lee SW, Kwak CH, Park SW. Adding cilostazol to dual antiplatelet therapy achieves greater platelet inhibition than high maintenance dose clopidogrel in patients with acute myocardial infarction: Results of the adjunctive cilostazol versus high maintenance dose clopidogrel in patients with AMI (ACCEL-AMI) study. Circ Cardiovasc Interv. 2010 Feb 1;3(1):17-26. doi: 10.1161/CIRCINTERVENTIONS.109.880179. Epub 2010 Jan 26.

Reference Type RESULT
PMID: 20118150 (View on PubMed)

Other Identifiers

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ACCEL-LOADING

Identifier Type: -

Identifier Source: org_study_id