Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome
Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome in Patients Undergoing Percutaneous Coronary Intervention for an Acute Coronary Syndrome
연구 개요
상세 설명
The use of thienopyridines in patients undergoing percutaneous coronary intervention (PCI) has dramatically decreased the rate of early stent thrombosis. Further the CURE trial demonstrated that long-term clopidogrel decreases the rate of major adverse cardiovascular events in acute coronary syndrome patients (ACS) . However clopidogrel has several limitations including a long delay of action which is a potential limitation in acute settings of coronary artery disease. Another major limitation of the drug is the wide inter individual variability in clopidogrel responsiveness related to various factors.
In addition recent studies suggested that platelet reactivity inhibition does also determine the bleeding risk.
The ticagrelor is a new blocker of the receiver P2Y12 which distinguishes itself from the clopidogrel by a superior biological efficiency. This biological property was translated in the study PLATO, having compared it with the clopidogrel in the ACS, by a reduction of the risk thrombotique. The ticagrelor is thus recommended in first intention in this indication. There seems be a variability of answer to the ticagrelor. Besides the ticagrelor infers a level of intense platelet inhibition which could explain on hemorrhagic risk which is associated with it.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Marseille, 프랑스, 13354
- Assistance Publique Hopitaux de Marseille
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Acute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines.
Exclusion criteria:
- New York Heart Association functional class III or IV
- Cardiac arrest
- Contra-indications to antiplatelet therapy
- Platelet count <100 G/l
- History of bleeding diathesis
- Concurrent severe illness with expected survival of < 1 year month
- Pregnant of childbearing woman
- Inability to provide an informed consent
- Contra indication to ticagrelor.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Acute coronary syndrome patient
Acute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines accepting blood samples measuring platelets reactivity
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Biological samples will be done to determine platelet reactivity testing by VASP-index, will be obtained between 6 and 12 hours after receiving ticagrelor
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Platelet reactivity inhibition measured by the VASP index 6 to 12 hours after the loading dose of ticagrelor
기간: one year
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Platelet reactivity inhibition measured by the VASP index 6 to 12 hours after the loading dose is associated with the occurrence of BARC bleedings ≥ 2 at one year post-PCI.
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one year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Relationship between VASP index and MACE
기간: 1 month
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the rate of major cardiovascular events ( MACE )
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1 month
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Relationship between VASP index and MACE
기간: 1 year
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1 year
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Relationship between VASP index and BARC
기간: 1month
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BARC: bleeding academic research complications
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1month
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Compliance to ticagrelor
기간: 1 year
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1 year
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Evaluate Adenosine deaminase
기간: 1 year
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1 year
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evaluate DDP IV activity
기간: 1 year
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1 year
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Evaluate microparticules number and activity under ticagrelor
기간: 1 year
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1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Laurent BONELLO, MD, Assistance Publique Hopitaux de Marseille
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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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