PRasugrEl-Monotherapie nach primärer perkutaner Koronarintervention bei Myokardinfarkt mit ST-Hebung (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).
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
-
-
Osaka
-
Sayama, Osaka, Japan, 589-8511
- Kindai University Faculty of Medicine
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: No aspirin (Prasugrel monotherapy)
To start prasugrel monotherapy before primary percutaneous coronary intervention (PCI). |
12-month prasugrel monotherapy
Andere Namen:
|
|
Aktiver Komparator: 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
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Major adverse cardiovascular events
Zeitfenster: 12 months
|
Composite of all-cause death, myocardial infarction, or stroke |
12 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Major secondary bleeding endpoint: Type 3 or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Zeitfenster: 12 months
|
Type 3 or 5 bleeding defined by BARC criteria |
12 months
|
|
All-cause death
Zeitfenster: 12 months
|
Death from any cause |
12 months
|
|
Cardiovascular death
Zeitfenster: 12 months
|
Death from cardiovascular cause |
12 months
|
|
Non-cardiovascular death
Zeitfenster: 12 months
|
Death from non-cardiovascular cause |
12 months
|
|
Myocardial infarction (Periprocedual/ Spontaneous)
Zeitfenster: 12 months
|
Defined by the Academic Research Consortium (ARC)-2 |
12 months
|
|
Stroke (Ischemic/ Haemorrhagic)
Zeitfenster: 12 months
|
Including both ischemic and haemorrhagic stroke |
12 months
|
|
Ischemic stroke
Zeitfenster: 12 months
|
Ischemic stroke with symptom lasting over 24 hours |
12 months
|
|
Hemorrhagic stroke
Zeitfenster: 12 months
|
Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma |
12 months
|
|
Stent thrombosis
Zeitfenster: 12 months
|
Stent thrombosis defined by Academic Research Consortium (ARC)-2 definition |
12 months
|
|
Target lesion failure
Zeitfenster: 12 months
|
Cardiovascular death, target vessel myocardial infarction, clinically indicated target lesion revascularization |
12 months
|
|
Target vessel failure
Zeitfenster: 12 months
|
Cardiovascular death, target vessel myocardial infarction, clinically indicated target vessel revascularization |
12 months
|
|
Patient-Oriented Composite Endpoint
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 12 months
|
Target lesion revascularization with the anginal symptoms or the positive test for ischemia |
12 months
|
|
Non-target lesion revascularization
Zeitfenster: 12 months
|
Revascularization to non-target lesions regardless PCI or CABG |
12 months
|
|
Coronary artery bypass grafting
Zeitfenster: 12 months
|
Any coronary artery bypass grafting |
12 months
|
|
Any target vessel revascularization
Zeitfenster: 12 months
|
Revascularization to the target vessel |
12 months
|
|
Any coronary revascularization
Zeitfenster: 12 months
|
Revascularization regardless of PCI or CABG |
12 months
|
|
Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Zeitfenster: 12 months
|
Type 2 bleeding defined by BARC criteria |
12 months
|
|
Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Zeitfenster: 12 months
|
Type 3 bleeding defined by BARC criteria |
12 months
|
|
Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Zeitfenster: 12 months
|
Type 4 bleeding defined by BARC criteria |
12 months
|
|
Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Zeitfenster: 12 months
|
Type 5 bleeding defined by BARC criteria |
12 months
|
|
Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Zeitfenster: 12 months
|
Type 2, 3, or 5 bleeding defined by BARC criteria |
12 months
|
|
Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Zeitfenster: 12 months
|
Major bleeding defined by TIMI criteria |
12 months
|
|
Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Zeitfenster: 12 months
|
Minor bleeding defined by TIMI criteria |
12 months
|
|
Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Zeitfenster: 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
Zeitfenster: 12 months
|
Severe bleeding defined by GUSTO criteria |
12 months
|
|
Moderate bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
Zeitfenster: 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
Zeitfenster: 12 months
|
Moderate or severe bleeding defined by GUSTO criteria |
12 months
|
|
Intracranial bleeding
Zeitfenster: 12 months
|
Intracranial bleeding regardless of spontaneous or trauma |
12 months
|
|
Gastrointestinal bleeding
Zeitfenster: 12 months
|
Bleeding from gastrointestinal tract regardless of severity |
12 months
|
|
Gastrointestinal complaints
Zeitfenster: 12 months
|
Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints |
12 months
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Gaku Nakazawa, MD, PhD, Kindai University Faculty of Medicine
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Pathologische Prozesse
- Herzkrankheiten
- Infarkt
- Nekrose
- Myokardischämie
- Herzinfarkt
- Ischämie
- Pathologische Zustände, Anzeichen und Symptome
- Myokardinfarkt mit ST-Hebung
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Andere Studien-ID-Nummern
- Y0140
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