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ST-segment Elevation Myocardial Infarction (STEMI)Phase 4PREMIUMNCT05709626

PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction

A Phase 4 study testing No aspirin (Prasugurel monotherapy) and 12-month DAPT in people with ST-segment Elevation Myocardial Infarction (STEMI), run by Kindai University at 1 site in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
No aspirin (Prasugurel monotherapy) and 12-month DAPT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,258 participants
Where
1 siteJapan
Study dates
28 Feb 2023to 4 Jan 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Patients taking anticoagulants
  • Patients under 18 years old
  • Patients with less than 1 year prognosis
  • Patients participating in other intervention studies

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kuniaki Takahashi, MD, PhD contact

+81-72-366-0221

kuniaki.t.0125@gmail.com

Japan1 site, 1 recruiting

  • Kindai University Faculty of Medicine

    Sayama, Osaka, 589-8511

    Gaku Nakazawa, MD, PhD

    Kuniaki Takahashi, MD, PhD

    Recruiting

Other trials in Japan

About this study

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).

Read the detailed description

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).

Being tested
No aspirin (Prasugurel monotherapy), 12-month DAPT
Keywords
Acute Coronary Syndrome, Dual AntiPlatelet Therapy, Drug Eluting Stent, Percutaneous Coronary Intervention, ST-elevation myocardial infarction
Medical subject headings
ST Elevation Myocardial Infarction, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No aspirin (Prasugurel monotherapy)Drug

    Also called Experimental arm

    12-month prasugrel monotherapy

  • 12-month DAPTDrug

    Also called Reference arm

    12-month dual antiplatelet therapy with prasugrel and aspirin

Study groups in NCT05709626
Study groupRoleWhat they receive
No aspirin (Prasugrel monotherapy)Active comparatorTo start prasugrel monotherapy before primary percutaneous coronary intervention (PCI).
Receives: Drug: No aspirin (Prasugurel monotherapy)
12-month DAPTActive comparatorTo start dual antiplatelet therapy with prasugrel and aspirin for 12 months before primary percutaneous coronary intervention (PCI).
Receives: Drug: 12-month DAPT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major adverse cardiovascular events

    Composite of all-cause death, myocardial infarction, or stroke

    Measured: 12 months

Secondary outcomes (32)

  1. Major secondary bleeding endpoint: Type 3 or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 3 or 5 bleeding defined by BARC criteria

    Measured: 12 months

  2. All-cause death

    Death from any cause

    Measured: 12 months

  3. Cardiovascular death

    Death from cardiovascular cause

    Measured: 12 months

  4. Non-cardiovascular death

    Death from non-cardiovascular cause

    Measured: 12 months

  5. Myocardial infarction (Periprocedual/ Spontaneous)

    Defined by the Academic Research Consortium (ARC)-2

    Measured: 12 months

  6. Stroke (Ischemic/ Haemorrhagic)

    Including both ischemic and haemorrhagic stroke

    Measured: 12 months

  7. Ischemic stroke

    Ischemic stroke with symptom lasting over 24 hours

    Measured: 12 months

  8. Hemorrhagic stroke

    Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma

    Measured: 12 months

  9. Stent thrombosis

    Stent thrombosis defined by Academic Research Consortium (ARC)-2 definition

    Measured: 12 months

  10. Target lesion failure

    Cardiovascular death, target vessel myocardial infarction, clinically indicated target lesion revascularization

    Measured: 12 months

  11. Target vessel failure

    Cardiovascular death, target vessel myocardial infarction, clinically indicated target vessel revascularization

    Measured: 12 months

  12. Patient-Oriented Composite Endpoint

    All-cause death, stroke, myocardial infarction, and all revascularization, defined by the Academic Research Consortium (ARC)-2

    Measured: 12 months

  13. Any target lesion revascularization

    Revascularization to the target lesions (including 5mm of both ends of the stent[s]) regardless of PCI or CABG

    Measured: 12 months

  14. Clinically-driven target lesion revascularization

    Target lesion revascularization with the anginal symptoms or the positive test for ischemia

    Measured: 12 months

  15. Non-target lesion revascularization

    Revascularization to non-target lesions regardless PCI or CABG

    Measured: 12 months

  16. Coronary artery bypass grafting

    Any coronary artery bypass grafting

    Measured: 12 months

  17. Any target vessel revascularization

    Revascularization to the target vessel

    Measured: 12 months

  18. Any coronary revascularization

    Revascularization regardless of PCI or CABG

    Measured: 12 months

  19. Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 2 bleeding defined by BARC criteria

    Measured: 12 months

  20. Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 3 bleeding defined by BARC criteria

    Measured: 12 months

  21. Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 4 bleeding defined by BARC criteria

    Measured: 12 months

  22. Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 5 bleeding defined by BARC criteria

    Measured: 12 months

  23. Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 2, 3, or 5 bleeding defined by BARC criteria

    Measured: 12 months

  24. Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria

    Major bleeding defined by TIMI criteria

    Measured: 12 months

  25. Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria

    Minor bleeding defined by TIMI criteria

    Measured: 12 months

  26. Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria

    Major or minor defined by TIMI criteria

    Measured: 12 months

  27. Severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria

    Severe bleeding defined by GUSTO criteria

    Measured: 12 months

  28. Moderate bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria

    Moderate bleeding defined by GUSTO criteria

    Measured: 12 months

  29. Moderate or severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria

    Moderate or severe bleeding defined by GUSTO criteria

    Measured: 12 months

  30. Intracranial bleeding

    Intracranial bleeding regardless of spontaneous or trauma

    Measured: 12 months

  31. Gastrointestinal bleeding

    Bleeding from gastrointestinal tract regardless of severity

    Measured: 12 months

  32. Gastrointestinal complaints

    Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2023
  2. Study start28 Feb 2023 (estimated)
  3. Primary completion4 Jan 2025 (estimated)
  4. Study completion4 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,258 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05709626
Sponsor's protocol ID
Y0140
Acronym
PREMIUM
Status last verified
Feb 2023
First submitted
19 Jan 2023
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 42670955

  • 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.

    PubMed 41436299

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing No aspirin (Prasugurel monotherapy) and 12-month DAPT in people with ST-segment Elevation Myocardial Infarction (STEMI), run by Kindai University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kuniaki Takahashi, MD, PhD (+81-72-366-0221, kuniaki.t.0125@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiovascular events (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05709626, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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