- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00589927
Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent (DECLARELONG)
Comparison of Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent Implantation For Long Coronary Lesions
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
-
Bucheon, Korea, Republikken
- SoonChunHyang University Bucheon Hospital
-
Cheonan, Korea, Republikken
- Soonchunhyang University Hospital, Cheonan
-
Chuncheon, Korea, Republikken
- Kangwon National University Hospital
-
Daejeon, Korea, Republikken
- Chungnam National University Hospital
-
PyeongChon, Korea, Republikken
- Hallym University Sacred Heart Hospital,
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Seoul, Korea, Republikken, 138-736
- Asan Medical Center
-
Seoul, Korea, Republikken
- Soonchunhyang University Seoul Hospital
-
Seoul, Korea, Republikken
- Hangang Sacred Heart Hospital
-
Seoul, Korea, Republikken
- Seoul Veterans Hospital
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Ulsan, Korea, Republikken
- Ulsan University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
- 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:
- History of bleeding diathesis or coagulopathy
- Pregnant
- Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus and paclitaxel
- Limited life-expectancy (less than 1 year) due to combined serious disease
- ST-elevation acute myocardial infarction
- Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels
- Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3)
- Hepatic dysfunction, liver enzyme (ALT and AST) elevation >3 times normal
- Renal dysfunction, creatinine >2.0mg/dL
- Contraindication to aspirin, clopidogrel or cilostazol
- planned bifurcation stenting
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: cilostazol
Cilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
|
cilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
|
Placebo komparator: placebo
Control placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
|
placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Angiographic in-stent late loss
Tidsramme: 8-months after randomization
|
8-months after randomization
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
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
Tidsramme: 12 months
|
12 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Seung-Wook Park, MD,PhD, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Myokardiskemi
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Arteriosklerose
- Arterielle okklusive sykdommer
- Koronar sykdom
- Koronararteriesykdom
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Vasodilaterende midler
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Enzymhemmere
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Blodplateaggregasjonshemmere
- Nevrobeskyttende midler
- Beskyttende agenter
- Bronkodilatatorer
- Anti-astmatiske midler
- Luftveismidler
- Fosfodiesterasehemmere
- Fosfodiesterase 3-hemmere
- Cilostazol
Andre studie-ID-numre
- 2007-0003
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