- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 장소
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Bucheon, 대한민국
- SoonChunHyang University Bucheon Hospital
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Cheonan, 대한민국
- Soonchunhyang University Hospital, Cheonan
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Chuncheon, 대한민국
- KangWon National University Hospital
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Daejeon, 대한민국
- Chungnam National University Hospital
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PyeongChon, 대한민국
- Hallym University Sacred Heart Hospital,
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Seoul, 대한민국, 138-736
- Asan Medical Center
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Seoul, 대한민국
- SoonChunHyang University Seoul Hospital
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Seoul, 대한민국
- Hangang Sacred Heart Hospital
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Seoul, 대한민국
- Seoul Veterans Hospital
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Ulsan, 대한민국
- Ulsan University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Angiographic in-stent late loss
기간: 8-months after randomization
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8-months after randomization
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2차 결과 측정
결과 측정 |
기간 |
---|---|
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
기간: 12 months
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12 months
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Seung-Wook Park, MD,PhD, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2007-0003
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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