- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01463163
Ticagrelor in Comparison to Prasugrel for Early Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
This is a single-center, randomized, single-blind, investigator-initiated, pharmacodynamic study with a parallel design. Patients with ST elevation myocardial infarction, undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1 ratio to the following treatment groups:
Group Α: Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD)starting 12±6 hours post LD, until Day 5 (5 days after randomization) Group Β: Prasugrel 60 mg LD followed by 10mg x1 MD starting 24 hours post LD, until Day 5 (5 days after randomization).
Platelet reactivity assessment will be performed at randomization (Hour 0) and at 1, 2, 6, 24 hours after randomization, and on Day 5. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and serious adverse events (bleeding, other adverse events)will be performed until Day 5.
연구 개요
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Achaia
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Rio, Achaia, 그리스, 26500
- Cardiology Department Patras University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ≥18 years old
- Patients with STEMI undergoing primary PCI with stenting
- Informed consent obtained in writing
Exclusion Criteria:
- Pregnancy
- Breastfeeding
- Inability to give informed consent or high likelihood of being unavailable until the Day 5
- Prior PCI performed within 30 days prior to randomization
- Cardiogenic shock
- Major periprocedural complications (death, stent thrombosis, vessel perforation, arrhythmias requiring cardioversion, temporary pacemaker insertion or intravenous antiarrhythmic agents, respiratory failure requiring intubation, vascular injury (arteriovenous shunt, retroperitoneal bleeding), major bleeding (need for bood transfusion or drop in haemoglobin post-PCI by ≥ 5 gr/ dl or intracranial bleeding).
- Unsuccessful PCI (residual stenosis > 30% or flow < ΤΙΜΙ 3) or planned staged PCI in the next 5 days after randomization
- Requirement for oral anticoagulant prior to the Day 5 visit
- Current or planned therapy with other thienopyridine class of ADP receptor inhibitors.
- Known hypersensitivity to prasugrel or ticagrelor
- History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
- Other bleeding diathesis, or considered by investigator to be at high risk for bleeding.
- Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- Thombocytopenia (<100.000 / μL) at randomization
- Anaemia (Hct <30%) at randomization
- Polycytaemia (Hct > 52%) at randomization
- Periprocedural IIb/IIIa inhibitors administration
- Severe allergy to contrast agent, unfractionated heparin, enoxaparin or bivalirudin that cannot be adequately premedicated.
- Recent (< 6 weeks) major surgery or trauma, including GABG.
- Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
- Concomitant oral or IV therapy with strong CY P3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazana vir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin /rifampicin, phenytoin, carbamazepine).
- Increased risk of bradycardiac events.
- Dialysis required.
- Severe uncontrolled chronic obstructive pulmonary disease
- Known severe hepatic impairement
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Prasugrel
Prasugrel 60mg LD followed by 10mg MD starting post 24 hours
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Prasugrel 60mg LD followed by 10mg x1 MD starting post 24 hours
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실험적: Ticagrelor
Ticagrelor 180mg LD followed by 90mg x2 MD starting post 12±6 hours
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Ticagrelor 180mg LD followed by 90mg x2 MD starting after 12±6 hours
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Platelet reactivity
기간: 1hour
|
Platelet reactivity Platelet assessed by VerifyNow P2Y12 assay 1 hour post randomization
|
1hour
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Platelet reactivity
기간: 1 hour
|
Platelet Reactivity assessed by Multiplate analyzer assay 1 hour post randomization
|
1 hour
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Platelet reactivity
기간: 2 hours
|
Platelet reactivity assessed by the VerifyNow assay 2 hours post randomization
|
2 hours
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Platelet reactivity
기간: 2 hours
|
Platelet Reactivity assessed by Multiplate analyzer 2 hours post randomization
|
2 hours
|
Platelet reactivity
기간: 6 hours
|
Platelet Reactivity assessed by VerifyNow P2Y12 assay 6 hours post randomization
|
6 hours
|
Platelet reactivity
기간: 6 hours
|
Platelet Reactivity assessed by Multiplate analyzer 6 hours post randomization
|
6 hours
|
Platelet reactivity
기간: 24 hours
|
Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization
|
24 hours
|
Platelet reactivity
기간: 24 hours
|
Platelet Reactivity assessed by Multiplate analyzer 24 hours post randomization
|
24 hours
|
Platelet reactivity
기간: 5 days
|
Platelet Reactivity assessed by VerifyNow P2Y12 assay 5 days post randomization
|
5 days
|
Platelet reactivity
기간: 5 days
|
Platelet Reactivity assessed by Multiplate analyzer 5 days post randomization
|
5 days
|
공동 작업자 및 조사자
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
- PATRASCARDIOLOGY-8
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, 독일, 이탈리아
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Azienda Ospedaliera Universitaria Integrata VeronaUniversity of Milan알려지지 않은
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IGLESIAS Juan FernandoClinical Trials Unit University of Bern아직 모집하지 않음