PRasugrEl Monotherapie na primaire percUtane coronaire interventie voor myocardinfarct met ST-elevatie (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).
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Osaka
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Sayama, Osaka, Japan, 589-8511
- Kindai University Faculty of Medicine
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: No aspirin (Prasugrel monotherapy)
To start prasugrel monotherapy before primary percutaneous coronary intervention (PCI). |
12-month prasugrel monotherapy
Andere namen:
|
|
Actieve vergelijker: 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:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Major adverse cardiovascular events
Tijdsspanne: 12 months
|
Composite of all-cause death, myocardial infarction, or stroke |
12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Major secondary bleeding endpoint: Type 3 or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Tijdsspanne: 12 months
|
Type 3 or 5 bleeding defined by BARC criteria |
12 months
|
|
All-cause death
Tijdsspanne: 12 months
|
Death from any cause |
12 months
|
|
Cardiovascular death
Tijdsspanne: 12 months
|
Death from cardiovascular cause |
12 months
|
|
Non-cardiovascular death
Tijdsspanne: 12 months
|
Death from non-cardiovascular cause |
12 months
|
|
Myocardial infarction (Periprocedual/ Spontaneous)
Tijdsspanne: 12 months
|
Defined by the Academic Research Consortium (ARC)-2 |
12 months
|
|
Stroke (Ischemic/ Haemorrhagic)
Tijdsspanne: 12 months
|
Including both ischemic and haemorrhagic stroke |
12 months
|
|
Ischemic stroke
Tijdsspanne: 12 months
|
Ischemic stroke with symptom lasting over 24 hours |
12 months
|
|
Hemorrhagic stroke
Tijdsspanne: 12 months
|
Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma |
12 months
|
|
Stent thrombosis
Tijdsspanne: 12 months
|
Stent thrombosis defined by Academic Research Consortium (ARC)-2 definition |
12 months
|
|
Target lesion failure
Tijdsspanne: 12 months
|
Cardiovascular death, target vessel myocardial infarction, clinically indicated target lesion revascularization |
12 months
|
|
Target vessel failure
Tijdsspanne: 12 months
|
Cardiovascular death, target vessel myocardial infarction, clinically indicated target vessel revascularization |
12 months
|
|
Patient-Oriented Composite Endpoint
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 12 months
|
Target lesion revascularization with the anginal symptoms or the positive test for ischemia |
12 months
|
|
Non-target lesion revascularization
Tijdsspanne: 12 months
|
Revascularization to non-target lesions regardless PCI or CABG |
12 months
|
|
Coronary artery bypass grafting
Tijdsspanne: 12 months
|
Any coronary artery bypass grafting |
12 months
|
|
Any target vessel revascularization
Tijdsspanne: 12 months
|
Revascularization to the target vessel |
12 months
|
|
Any coronary revascularization
Tijdsspanne: 12 months
|
Revascularization regardless of PCI or CABG |
12 months
|
|
Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Tijdsspanne: 12 months
|
Type 2 bleeding defined by BARC criteria |
12 months
|
|
Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Tijdsspanne: 12 months
|
Type 3 bleeding defined by BARC criteria |
12 months
|
|
Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Tijdsspanne: 12 months
|
Type 4 bleeding defined by BARC criteria |
12 months
|
|
Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Tijdsspanne: 12 months
|
Type 5 bleeding defined by BARC criteria |
12 months
|
|
Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Tijdsspanne: 12 months
|
Type 2, 3, or 5 bleeding defined by BARC criteria |
12 months
|
|
Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Tijdsspanne: 12 months
|
Major bleeding defined by TIMI criteria |
12 months
|
|
Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Tijdsspanne: 12 months
|
Minor bleeding defined by TIMI criteria |
12 months
|
|
Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Tijdsspanne: 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
Tijdsspanne: 12 months
|
Severe bleeding defined by GUSTO criteria |
12 months
|
|
Moderate bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
Tijdsspanne: 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
Tijdsspanne: 12 months
|
Moderate or severe bleeding defined by GUSTO criteria |
12 months
|
|
Intracranial bleeding
Tijdsspanne: 12 months
|
Intracranial bleeding regardless of spontaneous or trauma |
12 months
|
|
Gastrointestinal bleeding
Tijdsspanne: 12 months
|
Bleeding from gastrointestinal tract regardless of severity |
12 months
|
|
Gastrointestinal complaints
Tijdsspanne: 12 months
|
Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints |
12 months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Gaku Nakazawa, MD, PhD, Kindai University Faculty of Medicine
Publicaties en nuttige links
Algemene publicaties
- 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.
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Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Vaatziekten
- Hart-en vaatziekten
- Pathologische processen
- Hartziekten
- Infarct
- Necrose
- Myocardiale ischemie
- Myocardinfarct
- Ischemie
- Pathologische aandoeningen, tekenen en symptomen
- ST-elevatie myocardinfarct
- Acute kransslagader syndroom
- 2'-deoxythymidylyl- (3'-5 ')-2'-deoxyadenosine
- N-acetyl-S-(alpha-methyl-4-(2-methylpropyl)benzeneacetyl)cysteine 4-(nitrooxy)butyl ester
Andere studie-ID-nummers
- Y0140
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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