ST 상승 심근경색에 대한 1차 관상동맥 중재술 후 PRasugrEl 단일 요법 (PREMIUM)
The aim of this study is to evaluate the safety of prasugrel monotherapy without aspirin versus 12-month dual antiplatelet therapy (DAPT) in patients with STEMI using platinum-chrome everolimus-eluting stent (PtCr-EES: SYNERGYTM).
연구 개요
상세 설명
In the STOPDAPT-2 ACS trial (NCT03462498), ischemic events (especially myocardial infarction) was significantly increased with 1-month DAPT followed by clopidogrel monotherapy, as compared to 12-month DAPT in patients with acute coronary syndrome (ACS). This was potentially attributable to clopidogrel, instead of prasugrel, which is more potent and has less individual difference in efficacy. On the other hand, previous studies including the STOPDAPT-2 ACS that evaluated the safety and efficacy of monotherapy with a P2Y12 inhibitor without aspirin consistently and significantly reduced the risk of bleeding, compared with standard DAPT. Consequently, there has been growing necessity to establish the safety with P2Y12 inhibitor monotherapy in terms of major adverse cardiovascular events. Therefore, we have planned to evaluate the non-inferiority of P2Y12 inhibitor monotherapy with prasugrel versus standard 12-month DAPT with prasugrel and aspirin in terms of the incidence of major cardiovascular events at 12 months after primary PCI in patients with STEMI using Platinum-Chromium Everolimus Eluting Stent (PtCr-EES; SYNERGYTM).
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Osaka
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Sayama, Osaka, 일본, 589-8511
- Kindai University Faculty of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients scheduled for primary PCI with everolimus-eluting stent (PtCr-EES, SYNERGYTM)
- STEMI patients
- Patients who can continue dual antiplatelet therapy with aspirin and a P2Y12 inhibitor for 12 months
Exclusion Criteria:
- Patients taking anticoagulants
- Patients under 18 years old
- Patients with less than 1 year prognosis
- Patients participating in other intervention studies
공부 계획
연구는 어떻게 설계됩니까?
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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활성 비교기: No aspirin (Prasugrel monotherapy)
To start prasugrel monotherapy before primary percutaneous coronary intervention (PCI). |
12-month prasugrel monotherapy
다른 이름들:
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활성 비교기: 12-month DAPT
To start dual antiplatelet therapy with prasugrel and aspirin for 12 months before primary percutaneous coronary intervention (PCI). |
12-month dual antiplatelet therapy with prasugrel and aspirin
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Major adverse cardiovascular events
기간: 12 months
|
Composite of all-cause death, myocardial infarction, or stroke |
12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Major secondary bleeding endpoint: Type 3 or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
기간: 12 months
|
Type 3 or 5 bleeding defined by BARC criteria |
12 months
|
|
All-cause death
기간: 12 months
|
Death from any cause |
12 months
|
|
Cardiovascular death
기간: 12 months
|
Death from cardiovascular cause |
12 months
|
|
Non-cardiovascular death
기간: 12 months
|
Death from non-cardiovascular cause |
12 months
|
|
Myocardial infarction (Periprocedual/ Spontaneous)
기간: 12 months
|
Defined by the Academic Research Consortium (ARC)-2 |
12 months
|
|
Stroke (Ischemic/ Haemorrhagic)
기간: 12 months
|
Including both ischemic and haemorrhagic stroke |
12 months
|
|
Ischemic stroke
기간: 12 months
|
Ischemic stroke with symptom lasting over 24 hours |
12 months
|
|
Hemorrhagic stroke
기간: 12 months
|
Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma |
12 months
|
|
Stent thrombosis
기간: 12 months
|
Stent thrombosis defined by Academic Research Consortium (ARC)-2 definition |
12 months
|
|
Target lesion failure
기간: 12 months
|
Cardiovascular death, target vessel myocardial infarction, clinically indicated target lesion revascularization |
12 months
|
|
Target vessel failure
기간: 12 months
|
Cardiovascular death, target vessel myocardial infarction, clinically indicated target vessel revascularization |
12 months
|
|
Patient-Oriented Composite Endpoint
기간: 12 months
|
All-cause death, stroke, myocardial infarction, and all revascularization, defined by the Academic Research Consortium (ARC)-2 |
12 months
|
|
Any target lesion revascularization
기간: 12 months
|
Revascularization to the target lesions (including 5mm of both ends of the stent[s]) regardless of PCI or CABG |
12 months
|
|
Clinically-driven target lesion revascularization
기간: 12 months
|
Target lesion revascularization with the anginal symptoms or the positive test for ischemia |
12 months
|
|
Non-target lesion revascularization
기간: 12 months
|
Revascularization to non-target lesions regardless PCI or CABG |
12 months
|
|
Coronary artery bypass grafting
기간: 12 months
|
Any coronary artery bypass grafting |
12 months
|
|
Any target vessel revascularization
기간: 12 months
|
Revascularization to the target vessel |
12 months
|
|
Any coronary revascularization
기간: 12 months
|
Revascularization regardless of PCI or CABG |
12 months
|
|
Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria
기간: 12 months
|
Type 2 bleeding defined by BARC criteria |
12 months
|
|
Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria
기간: 12 months
|
Type 3 bleeding defined by BARC criteria |
12 months
|
|
Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria
기간: 12 months
|
Type 4 bleeding defined by BARC criteria |
12 months
|
|
Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
기간: 12 months
|
Type 5 bleeding defined by BARC criteria |
12 months
|
|
Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
기간: 12 months
|
Type 2, 3, or 5 bleeding defined by BARC criteria |
12 months
|
|
Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
기간: 12 months
|
Major bleeding defined by TIMI criteria |
12 months
|
|
Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
기간: 12 months
|
Minor bleeding defined by TIMI criteria |
12 months
|
|
Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
기간: 12 months
|
Major or minor defined by TIMI criteria |
12 months
|
|
Severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
기간: 12 months
|
Severe bleeding defined by GUSTO criteria |
12 months
|
|
Moderate bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
기간: 12 months
|
Moderate bleeding defined by GUSTO criteria |
12 months
|
|
Moderate or severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
기간: 12 months
|
Moderate or severe bleeding defined by GUSTO criteria |
12 months
|
|
Intracranial bleeding
기간: 12 months
|
Intracranial bleeding regardless of spontaneous or trauma |
12 months
|
|
Gastrointestinal bleeding
기간: 12 months
|
Bleeding from gastrointestinal tract regardless of severity |
12 months
|
|
Gastrointestinal complaints
기간: 12 months
|
Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints |
12 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Gaku Nakazawa, MD, PhD, Kindai University Faculty of Medicine
간행물 및 유용한 링크
일반 간행물
- Inaba S, Ogita M, Suwa S, Kashiwabara K, Wada H, Endo H, Shitara J, Nanasato M, Muramatsu T, Anzai H, Shirakabe A, Yamamoto M, Asaumi Y, Sakuma M, Okayama H, Takahashi K, Otake H, Ikari Y, Kozuma K, Morino Y, Nakazawa G. High Bleeding Risk and Aspirin Omission at the Time of Primary PCI in STEMI: A Post Hoc Analysis of the PREMIUM Trial. J Am Coll Cardiol. 2026 Oct 31:S0735-1097(26)10254-X. doi: 10.1016/j.jacc.2026.10.058. Online ahead of print.
- Takahashi K, Kozuma K, Morino Y, Kashiwabara K, Otake H, Suwa S, Nanasato M, Muramatsu T, Anzai H, Shirakabe A, Yamamoto M, Asaumi Y, Sakuma M, Okayama H, Nakabayashi K, Ogata N, Jujo K, Wakabayashi K, Kusuyama T, Onishi Y, Ashida K, Mitsuhashi Y, Nishimoto Y, Yamazaki S, Kuriyama N, Ikari Y, Nakazawa G; PREMIUM Trial Investigators. Aspirin Omission at the Time of Primary Percutaneous Coronary Intervention in STEMI. N Engl J Med. 2026 Aug 29. doi: 10.1056/NEJMoa2606997. Online ahead of print.
- Takahashi K, Kozuma K, Morino Y, Kashiwabara K, Otake H, Suwa S, Nanasato M, Muramatsu T, Anzai H, Shirakabe A, Yamamoto M, Asaumi Y, Sakuma M, Okayama H, Ikari Y, Nakazawa G. Prasugrel monotherapy versus 12-month dual antiplatelet therapy in STEMI patients undergoing intravascular imaging-guided PCI: Study design and rationale of the randomized PREMIUM trial. Cardiovasc Revasc Med. 2026 Aug;89:30-36. doi: 10.1016/j.carrev.2025.12.007. Epub 2025 Dec 11.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Y0140
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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