NCT01354808

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Last Updated

September 24, 2013

Status Verified

September 1, 2013

Enrollment Period

2 years

First QC Date

May 15, 2011

Last Update Submit

September 23, 2013

Conditions

Platelet Aggregation InhibitorsAnti-inflammatory AgentMyocardial Reperfusion Injury

Keywords

CilostazolPlateletInflammationMyonecrosis

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular events (MACE)

    Composite of cardiac death, MI and ischemia-driven target lesion revascularization (TLR)

    1 month

Secondary Outcomes (6)

  • P2Y12 reaction unit levels in the 2 arms

    1 month

  • MACE incidence according to P2Y12 reaction unit

    1 month

  • any post-procedural increase of markers of myocardial injury above ULN

    1 month

  • post-procedural variations from baseline of hs-CRP levels in the 2 arms

    1 month

  • ACUITY major/minor bleeding rate

    1 month

  • +1 more secondary outcomes

Study Arms (2)

DAPT

ACTIVE COMPARATOR
Drug: Dual Anti-Platelet Therapy (DAPT)

TAPT

EXPERIMENTAL
Drug: Triple Anti-Platelet Therapy (TAPT)

Interventions

Dual Anti-Platelet Therapy (DAPT)DRUG

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

DAPT
Triple Anti-Platelet Therapy (TAPT)DRUG

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

TAPT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years of age
  • Non-ST-elevation ACS patients undergoing PCI within 48 hours after hospitalization

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gyeonsang National University Hospital

Jinju, Gyeonsangnam-do, 660-702, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 17394957RESULT

  • 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.

    PMID: 20118150RESULT

MeSH Terms

Conditions

Myocardial Reperfusion InjuryInflammation

Interventions

Dual Anti-Platelet Therapy

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesReperfusion InjuryPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy, CombinationDrug TherapyTherapeutics

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2011

First Posted

May 17, 2011

Study Start

July 1, 2010

Primary Completion

July 1, 2012

Last Updated

September 24, 2013

Record last verified: 2013-09

Locations

KR(1)