Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent

Coronary Artery Disease Clinical Trial

— DECLARELONG  

Official title:

Comparison of Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent Implantation For Long Coronary Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00589927
• Other study ID #: 2007-0003
• Status: Completed
• Phase: Phase 4
• First received: December 31, 2007
• Last updated: March 17, 2010
• Start date: December 2007
• Est. completion date: February 2010

Study information

• Verified date: July 2009
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• cilostazol
cilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
• placebo
placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months

Locations

Country	Name	City	State
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	Asan Medical Center	Seoul
Korea, Republic of	Hangang Sacred Heart Hospital	Seoul
Korea, Republic of	Seoul Veterans Hospital	Seoul
Korea, Republic of	Soonchunhyang University Seoul Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
CardioVascular Research Foundation, Korea	Otsuka Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic in-stent late loss		8-months after randomization	No
Secondary	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		12 months	Yes