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
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
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Bucheon、大韓民国
- Soonchunhyang University Bucheon Hospital
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Cheonan、大韓民国
- Soonchunhyang University Hospital, Cheonan
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Chuncheon、大韓民国
- Kangwon National University Hospital
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Daejeon、大韓民国
- Chungnam National University Hospital
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PyeongChon、大韓民国
- Hallym University Sacred Heart Hospital,
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Seoul、大韓民国、138-736
- Asan Medical Center
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Seoul、大韓民国
- Soonchunhyang University Seoul Hospital
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Seoul、大韓民国
- Hangang Sacred Heart Hospital
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Seoul、大韓民国
- Seoul Veterans Hospital
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Ulsan、大韓民国
- Ulsan University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:cilostazol
Cilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
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cilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
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プラセボコンパレーター:placebo
Control placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
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placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Angiographic in-stent late loss
時間枠:8-months after randomization
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8-months after randomization
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二次結果の測定
結果測定 |
時間枠 |
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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
時間枠:12 months
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12 months
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協力者と研究者
協力者
捜査官
- 主任研究者:Seung-Wook Park, MD,PhD、Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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