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Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent (DECLARELONG)
This study is currently recruiting participants.
Verified by CardioVascular Research Foundation, Korea, December 2007
First Received: December 31, 2007   No Changes Posted
Sponsors and Collaborators: CardioVascular Research Foundation, Korea
Korea Otsuka International Asia Arab
Information provided by: CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT00589927
  Purpose

To evaluate whether the cilostazol reduce neointimal hyperplasia after ZES (Zotarolimus-eluting stents) implantation, we performed double-blind,randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin plus clopidogrel plus cilostazol) and dual antiplatelet therapy (aspirin plus clopidogrel) for 8 months in patients with long coronary lesion treated with ZES.


Condition Intervention Phase
Coronary Artery Disease
Drug: Cilostazol
Phase IV

MedlinePlus related topics: Coronary Artery Disease
Drug Information available for: Cilostazol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Comparision of Triple Verus Dual Antiplatelet Therapy After ABT578-Eluting Stent Implnatation For Long Coronary Lesions

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • Angiographic in-stent late loss [ Time Frame: 8-months after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite of death, MI, and target lesion or vessel revascularization at 12 months, In-stent and in-stent restenosis at 8 months, In-segment late loss at 8 months Adverse side effects during treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 486
Study Start Date: April 2007
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A1: Experimental
Cilostazol
Drug: Cilostazol
Phosphodiesterase inhibitor
A2: Placebo Comparator
Control placebo
Drug: Cilostazol
Phosphodiesterase inhibitor

Detailed Description:

Use of drug-eluting stent (DES) has reduced the incidence of restenosis rate and the need for repeat revascularization compared to using bare metal stents. DES implantation also significantly reduced the angiographic restenosis in patients with long coronary lesions.However, although the use of DES has decreased the effect of lesion length on restenosis, the restenosis after DES implantation of long coronary lesions remain at a higher risk of restenosis. Cilostazol, a phosphodiesterase III inhibitor, has been known to reduce smooth muscle proliferation and intimal hyperplasia after endothelial injury and restenosis after balloon angioplasty and bare-metal stent (BMS) implantation when compared with aspirin and clopidogrel or ticlopidine. Recently, the impact of 6-month cilostazol treatment in addition to aspirin and clopidogrel on neointimal hyperplasia after sirolimus-(SES) or paclitaxel-eluting stent (PES) implantation for long-coronary lesions has been evaluated in our institution. It reported that cilostazol treatment achieved primary end point (in-stent late loss) and reduced need of target lesion revascularization without significant adverse drug-side effects with open-label design, which suggest that 6-month treatment of cilostazol effectively inhibits the neointimal hyperplasia after DES implantation and can be safely applied to the patients or lesions with higher risk of restenosis such as diabetes and long lesions.However, our study was done in unblined manner and might underestimate the angiographic results due to relatively short-term follow-up angiographic follow-up(6-month.

Recently commercially available new-DES, zotarolimus-leuting stent (ZES) demonstrated significant reduction of restenosis and cardiac events during 9-month. However, it has not been tested that 8-month treatment of cilostazol also effectively inhibits the neointimal hyperplasia after ZES implantation in patients with long coronary lesions. Therefore, to evaluate whether the cilostazol reduce neointimal hyperplasia after ZES implantation, We performed double-blind, randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin plus clopidogrel plus cilostazol) and dual antiplatelet therapy (aspirin plus clopidogrel) for 8 months in patients with long coronary lesion treated with ZES.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical 1) Patients with angina and documented ischemia or patients with documented silent ischemia 2) Patients who are eligible for intracoronary stenting 3) Age >18 years, <75 ages
  2. Angiographic 1) De novo lesion 2) Percent diameter stenosis ≥50% 3) Reference vessel size >2.5 mm by visual estimation 4) Lesion length >25 mm by visual estimation that is required for long Endeavor stent implantation (planned total stent length >30mm)

Exclusion Criteria:

  1. History of bleeding diathesis or coagulopathy
  2. Pregnant
  3. Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus and paclitaxel
  4. Limited life-expectancy (less than 1 year) due to combined serious disease
  5. ST-elevation acute myocardial infarction
  6. Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels
  7. Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3)
  8. Hepatic dysfunction, liver enzyme (ALT and AST) elevation >3 times normal
  9. Renal dysfunction, creatinine >2.0mg/dL
  10. Contraindication to aspirin, clopidogrel or cilostazol
  11. planned bifurcation stenting
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589927

Contacts
Contact: Seong-Wook Park, MD, PhD 2-3010-3153 ext 82 swpark@amc.seoul.kr
Contact: Seung-Whan Lee, MD, PhD 2-3010-3170 ext 82 seungwlee@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Seong-Wook Park, MD, PhD     2-3010-3153 ext 82     swpark@amc.seoul.kr    
Contact: Seung-Whan Lee, MD, PhD     2-3010-3170 ext 82     seungwlee@amc.seoul.kr    
Principal Investigator: Seong-Wook Park, DM, PhD            
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: In-Whan Seong, MD, PhD            
Principal Investigator: In-Whan Seong, MD, PhD            
Hangang Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of
Contact: Min-Gyu Kim, MD            
Principal Investigator: Min-Gyu Kim, MD            
Kangwon National University Hospital Recruiting
Chuncheon, Korea, Republic of
Contact: Bong-Ki Lee, MD, PhD            
Principal Investigator: Bong-Ki Lee, MD, PhD            
Seoul Veterans Hospital Recruiting
Seoul, Korea, Republic of
Contact: Keun Lee, MD, PhD            
Principal Investigator: Keun Lee, MD, PhD            
Soonchunhyang University Hospital, Cheonan Recruiting
Cheonan, Korea, Republic of
Contact: Dong-Gyu Jin, MD, PhD            
Principal Investigator: Dong-Gyu Jin, MD, PhD            
Hallym University Sacred Heart Hospital, Recruiting
PyeongChon, Korea, Republic of
Contact: Young-Jin Choi, MD, PhD            
Principal Investigator: Young-Jin Choi, MD, PhD            
Soonchunhyang University Bucheon Hospital Recruiting
Bucheon, Korea, Republic of
Contact: Nae-Hee Lee, MD, PhD            
Principal Investigator: Nae-Hee Lee, MD, PhD            
Soonchunhyang University Seoul Hospital Recruiting
Seoul, Korea, Republic of
Contact: Min-Su Hyun, MD, PhD            
Principal Investigator: Min-Su Hyun, MD, PhD            
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Sang-Gon Lee, MD, PhD            
Principal Investigator: Sang-Gon Lee, MD, PhD            
Sponsors and Collaborators
CardioVascular Research Foundation, Korea
Korea Otsuka International Asia Arab
Investigators
Principal Investigator: Seung-Wook Park, MD,PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

No publications provided

Responsible Party: Asan Medical Center ( Seong-Wook Park, MD, PhD )
Study ID Numbers: 2007-0003
Study First Received: December 31, 2007
Last Updated: December 31, 2007
ClinicalTrials.gov Identifier: NCT00589927     History of Changes
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
stents
cilostazol

Study placed in the following topic categories:
Arterial Occlusive Diseases
Cilostazol
Vasodilator Agents
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Anti-Asthmatic Agents
Fibrinolytic Agents
Cardiovascular Agents
Ischemia
Arteriosclerosis
Neuroprotective Agents
Coronary Disease
Fibrin Modulating Agents
Phosphodiesterase Inhibitors
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Bronchodilator Agents
Coronary Artery Disease

Additional relevant MeSH terms:
Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Arteriosclerosis
Neuroprotective Agents
Fibrin Modulating Agents
Therapeutic Uses
Cardiovascular Diseases
Arterial Occlusive Diseases
Cilostazol
Heart Diseases
Vascular Diseases
Anti-Asthmatic Agents
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Coronary Disease
Phosphodiesterase Inhibitors
Autonomic Agents
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009