Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent (DECLARELONG)

This study has been completed.
Sponsor:
Collaborator:
Otsuka Korea
Information provided by:
CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT00589927
First received: December 31, 2007
Last updated: March 17, 2010
Last verified: July 2009
  Purpose

To evaluate whether the cilostazol reduce neointimal hyperplasia after ZES (Zotarolimus-eluting stents) implantation, the investigators 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
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent Implantation For Long Coronary Lesions

Resource links provided by NLM:


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: December 2007
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cilostazol
Cilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
Drug: cilostazol
cilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
Other Name: cilostazol
Placebo Comparator: placebo
Control placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
Drug: placebo
placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
Other Name: placebo

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 unblinded 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-eluting 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, the investigators 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589927

Locations
Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of
Soonchunhyang University Hospital, Cheonan
Cheonan, Korea, Republic of
Kangwon National University Hospital
Chuncheon, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Hallym University Sacred Heart Hospital,
PyeongChon, Korea, Republic of
Hangang Sacred Heart Hospital
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Soonchunhyang University Seoul Hospital
Seoul, Korea, Republic of
Seoul Veterans Hospital
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
CardioVascular Research Foundation, Korea
Otsuka Korea
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: Seong-Wook Park, MD, PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00589927     History of Changes
Other Study ID Numbers: 2007-0003
Study First Received: December 31, 2007
Last Updated: March 17, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
stents
cilostazol

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cilostazol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 11, 2014