ST上昇型心筋梗塞に対する一次経皮的冠動脈インターベンション後のPRasugrEL単剤療法 (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).
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Osaka
-
Sayama、Osaka、日本、589-8511
- Kindai University Faculty of Medicine
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：No aspirin (Prasugrel monotherapy)
To start prasugrel monotherapy before primary percutaneous coronary intervention (PCI). |
12-month prasugrel monotherapy
他の名前：
|
|
アクティブコンパレータ：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
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Major adverse cardiovascular events
時間枠：12 months
|
Composite of all-cause death, myocardial infarction, or stroke |
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Major secondary bleeding endpoint: Type 3 or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
時間枠：12 months
|
Type 3 or 5 bleeding defined by BARC criteria |
12 months
|
|
All-cause death
時間枠：12 months
|
Death from any cause |
12 months
|
|
Cardiovascular death
時間枠：12 months
|
Death from cardiovascular cause |
12 months
|
|
Non-cardiovascular death
時間枠：12 months
|
Death from non-cardiovascular cause |
12 months
|
|
Myocardial infarction (Periprocedual/ Spontaneous)
時間枠：12 months
|
Defined by the Academic Research Consortium (ARC)-2 |
12 months
|
|
Stroke (Ischemic/ Haemorrhagic)
時間枠：12 months
|
Including both ischemic and haemorrhagic stroke |
12 months
|
|
Ischemic stroke
時間枠：12 months
|
Ischemic stroke with symptom lasting over 24 hours |
12 months
|
|
Hemorrhagic stroke
時間枠：12 months
|
Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma |
12 months
|
|
Stent thrombosis
時間枠：12 months
|
Stent thrombosis defined by Academic Research Consortium (ARC)-2 definition |
12 months
|
|
Target lesion failure
時間枠：12 months
|
Cardiovascular death, target vessel myocardial infarction, clinically indicated target lesion revascularization |
12 months
|
|
Target vessel failure
時間枠：12 months
|
Cardiovascular death, target vessel myocardial infarction, clinically indicated target vessel revascularization |
12 months
|
|
Patient-Oriented Composite Endpoint
時間枠：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
時間枠：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
時間枠：12 months
|
Target lesion revascularization with the anginal symptoms or the positive test for ischemia |
12 months
|
|
Non-target lesion revascularization
時間枠：12 months
|
Revascularization to non-target lesions regardless PCI or CABG |
12 months
|
|
Coronary artery bypass grafting
時間枠：12 months
|
Any coronary artery bypass grafting |
12 months
|
|
Any target vessel revascularization
時間枠：12 months
|
Revascularization to the target vessel |
12 months
|
|
Any coronary revascularization
時間枠：12 months
|
Revascularization regardless of PCI or CABG |
12 months
|
|
Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria
時間枠：12 months
|
Type 2 bleeding defined by BARC criteria |
12 months
|
|
Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria
時間枠：12 months
|
Type 3 bleeding defined by BARC criteria |
12 months
|
|
Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria
時間枠：12 months
|
Type 4 bleeding defined by BARC criteria |
12 months
|
|
Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
時間枠：12 months
|
Type 5 bleeding defined by BARC criteria |
12 months
|
|
Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
時間枠：12 months
|
Type 2, 3, or 5 bleeding defined by BARC criteria |
12 months
|
|
Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
時間枠：12 months
|
Major bleeding defined by TIMI criteria |
12 months
|
|
Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
時間枠：12 months
|
Minor bleeding defined by TIMI criteria |
12 months
|
|
Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
時間枠：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
時間枠：12 months
|
Severe bleeding defined by GUSTO criteria |
12 months
|
|
Moderate bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
時間枠：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
時間枠：12 months
|
Moderate or severe bleeding defined by GUSTO criteria |
12 months
|
|
Intracranial bleeding
時間枠：12 months
|
Intracranial bleeding regardless of spontaneous or trauma |
12 months
|
|
Gastrointestinal bleeding
時間枠：12 months
|
Bleeding from gastrointestinal tract regardless of severity |
12 months
|
|
Gastrointestinal complaints
時間枠：12 months
|
Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints |
12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Gaku Nakazawa, MD, PhD、Kindai University Faculty of Medicine
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Y0140
個々の参加者データ (IPD) の計画
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