Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI) (TRIGGER-PCI)
2012년 5월 8일 업데이트: Eli Lilly and Company
Effectiveness of Prasugrel Versus Clopidogrel in Subjects With High Platelet Reactivity on Clopidogrel Following Elective Percutaneous Coronary Intervention With Implantation of Drug-Eluting Stent
To determine the efficacy of prasugrel versus clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents.
To determine the adverse event profile of prasugrel in patients with high platelet reactivity on clopidogrel after implantation of coronary drug-eluting stents.
To determine the effect of prasugrel on inhibition of platelet activation in patients with high platelet reactivity on clopidogrel.
연구 개요
연구 유형
중재적
등록 (실제)
423
단계
- 2 단계
연락처 및 위치
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연구 장소
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Bad Berka, 독일, 99437
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Bad Krozingen, 독일, 79189
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Bad Segeberg, 독일, 23795
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Berlin, 독일, 12203
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Bremen, 독일, 28277
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Dortmund, 독일, 44137
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Essen, 독일, 45147
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Freiburg, 독일, 79106
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Fulda, 독일, 36043
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Hamburg, 독일, 20246
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Leipzig, 독일, 04289
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Mainz, 독일, 55131
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Munich, 독일, 80636
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Pforzheim, 독일, 75175
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Stuttgart, 독일, 70376
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Tuebingen, 독일, 72076
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Villingen-Schwenningen, 독일, 78050
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Wuppertal, 독일, 42117
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Florida
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Clearwater, Florida, 미국, 33756
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Jacksonville, Florida, 미국, 32209
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Georgia
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Rome, Georgia, 미국, 30165
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Illinois
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Moline, Illinois, 미국, 61265
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New York
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New York, New York, 미국, 10021
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Oregon
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Portland, Oregon, 미국, 97225
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
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South Dakota
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Rapid City, South Dakota, 미국, 55701
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Tennessee
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Nashville, Tennessee, 미국, 37203
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Key Inclusion Criteria:
- Have coronary artery disease and clinical indication for percutaneous coronary intervention (PCI) with implantation of at least one drug-eluting stent and where percutaneous coronary intervention of all treated lesions is successful.
- Have been given standard-of-care clopidogrel 600-mg loading dose between 24 hours before and at the time of PCI.
- Standard of Care Aspirin use prior to PCI - at least 250-mg [intravenous (IV) or oral] within 24 hours before PCI and at the time of PCI.
- VerifyNow P2Y12 reaction units > 208 measured 2-7 hours after clopidogrel maintenance dose the day after successful PCI.
Exclusion Criteria:
- Non-ST segment elevation myocardial infarction within 14 days prior to randomization
- ST-segment elevation myocardial infarction within 14 days prior to randomization
- Have known major complications after percutaneous coronary intervention and prior to randomization
- Have a body weight < 60 kilogram (kg)
- Have cardiogenic shock at time of randomization
- Have refractory ventricular arrhythmias
- Have New York Heart Association Class IV congestive heart failure
- Have received glycoprotein (GP) IIb/IIIa inhibitors eptifibatide or tirofiban within 24 hrs before or during percutaneous coronary intervention or abciximab within 10 days before or during percutaneous coronary intervention
- Are receiving daily treatment with nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued or are anticipated to require > 2 weeks of daily treatment during the study
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 클로피도그렐
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75 mg oral daily maintenance dose up to 6 months.
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실험적: Prasugrel
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One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)
기간: Baseline through 6 months
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The endpoint in this measure is a combination of cardiovascular death or MI.
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Baseline through 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Stent Thrombosis (ST)
기간: Baseline through 6 months
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Academic Research Consortium (ARC) criteria was used to define ST.
Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers.
Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause.
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Baseline through 6 months
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Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)
기간: Baseline through 6 months
|
The endpoint in this measure is a combination of all-cause death or MI.
|
Baseline through 6 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2009년 7월 1일
기본 완료 (실제)
2011년 4월 1일
연구 완료 (실제)
2011년 4월 1일
연구 등록 날짜
최초 제출
2009년 5월 28일
QC 기준을 충족하는 최초 제출
2009년 5월 28일
처음 게시됨 (추정)
2009년 5월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 6월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 5월 8일
마지막으로 확인됨
2012년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 12323
- H7T-MC-TACW (기타 식별자: Eli Lilly and Company)
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. .
Prasugrel에 대한 임상 시험
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Research Maatschap Cardiologen Rotterdam ZuidAbbott Medical Devices모병ST 상승된 심근 경색증 | 이중 항혈소판 요법네덜란드, 세르비아, 벨기에, 독일, 이탈리아, 체코
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Azienda Ospedaliera Universitaria Integrata VeronaUniversity of Milan알려지지 않은
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J.P.S Henriques모병경피적 관상동맥 중재술(PCI) | 관상 동맥 질환(CAD)네덜란드
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University of Florida모병경피적 관상동맥 중재술(PCI) | 관상 동맥 질환(CAD)미국
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University of Florida모병
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Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa...Medical Research Agency, Poland모병
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IGLESIAS Juan FernandoClinical Trials Unit University of Bern모병