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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

December 31, 2007
March 17, 2010
December 2007
December 2009   (final data collection date for primary outcome measure)
Angiographic in-stent late loss [ Time Frame: 8-months after randomization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00589927 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent
Comparison of Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent Implantation For Long Coronary Lesions

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: cilostazol
    cilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
    Other Name: cilostazol
  • Drug: placebo
    placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
    Other Name: placebo
  • Experimental: cilostazol
    Cilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
    Intervention: Drug: cilostazol
  • Placebo Comparator: placebo
    Control placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
486
February 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00589927
2007-0003
Yes
Seong-Wook Park, MD, PhD, Asan Medical Center
CardioVascular Research Foundation, Korea
Otsuka Korea
Principal Investigator: Seung-Wook Park, MD,PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
CardioVascular Research Foundation, Korea
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP