Continuous Clopidogrel Dose Adjustment in Acute Coronary Syndrome Patients With High On-treatment Platelet Reactivity
Effect of Continuous Clopidogrel Dosing Targeted After Platelet Function Testing in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention With High On-treatment Platelet Reactivity
연구 개요
상세 설명
Dual antiplatelet therapy (DAPT) with aspirin and P2Y12 receptor antagonists during 12 months presents cornerstone treatment in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). Clopidogrel is the most widely used P2Y12 inhibitor despite it's limitations that include highly variable P2Y12-receptor inhibition which causes wide interindividual platelet reactivity variability. Since high on-treatment platelet reactivity (HTPR) on clopidogrel is strongly associated with adverse events, antiplatelet therapy tailoring has been vastly investigated to determine whether individualized approach could improve outcomes. In the time of progressive personalized approach to therapy, effective strategies are needed to minimize the risk of ischemic adverse events without increasing the risk for bleeding.
Aim of this study is to investigate whether continuous clopidogrel dose adjustment according to platelet function testing (PFT) using Multiplate® function analyzer (Roche Diagnostics, Mannheim, Germany) could decrease the rate of adverse events in ACS patients treated with PCI and with HTPR during early and late period of DAPT treatment.
Cut off values for HTPR and enhanced platelet response were set according to the consensus statement at >46 U and <19 U, respectively. PFT and therapy tailoring was performed at day 1, 2, 3, 7, 30 and month 2, 3, 6, 9 and 12.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Zagreb, 크로아티아, 10000
- University Hospital Centre Zagreb
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참여기준
자격 기준
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연구 대상 성별
설명
Inclusion Criteria:
- acute coronary syndrome patients treated with successful PCI
- age 18-80 years
- determined high on-treatment platelet reactivity
Exclusion Criteria:
- continuous postinterventional glycoprotein (GP) IIbIIIa receptor inhibitor infusion
- thrombocytopenia (<150x109/L)
- significant renal insufficiency (creatinine>200 µmol/L)
- anemia (Htc<30%)
- hemorrhagic diathesis
- history of intracranial bleeding or ischemic cerebrovascular insult 6 months before
- major operation 6 weeks before
- concomitant chronic anticoagulation therapy
- age <18 years and >80 years
공부 계획
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: control group
Patients in this group will receive standard clopidogrel dose
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실험적: interventional group
Patients in the interventional arm will receive clopidogrel dose adjustment to maintain optimal platelet reactivity determined by Multiplate function analyzer (19-46U). They will undergo platelet function testing on day 1,2,3,7,30 and month 2,3,6,9 and 12. On first two measurements patients will receive up to 2 additional clopidogrel loading doses (600 mg) and put on 150 mg and 75 mg a day if platelet reactivity >18U and <18U, respectively. Maintenance dose will be determined on following measurements - increased by 75 mg if >46U; not changed if 19-46U; decreased by 75 mg if <19U. Minimal dose - 75 mg; maximal dose 300 mg (for patients >70 years 150 mg) |
Patients in the interventional arm will receive clopidogrel dose adjustment to maintain optimal platelet reactivity determined by Multiplate function analyzer (19-46U). They will undergo platelet function testing on day 1,2,3,7,30 and month 2,3,6,9 and 12. On first two measurements patients will receive up to 2 additional clopidogrel loading doses (600 mg) and put on 150 mg and 75 mg a day if platelet reactivity >18U and <18U, respectively. Maintenance dose will be determined on following measurements - increased by 75 mg if >46U; not changed if 19-46U; decreased by 75 mg if <19U. Minimal dose - 75 mg; maximal dose 300 mg (for patients >70 years 150 mg)
다른 이름들:
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주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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clinical outcome - composite endpoint of total cardiovascular death, non-fatal myocardial infarction, target vessel revascularization and ischemic stroke
기간: 12 months
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Data will be collected during the entire follow up period on interviews and analyzing patient medical data.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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number of bleeding events
기간: 12 months
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BARC classification (Bleeding Academic Research Consortium)
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12 months
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공동 작업자 및 조사자
수사관
- 연구 의자: Davor Milicic, MD, PhD, University of Zagreb School of Medicine
- 수석 연구원: Jure Samardzic, MD, University of Zagreb School of Medicine
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
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 108-1081875-1993-1
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