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NCT Number: NCT05709626

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

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).

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Key information

Conditions

ST-segment Elevation Myocardial Infarction (STEMI) Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kindai University Faculty of Medicine

Sayama, Osaka, 589-8511, Japan

Location status: Recruiting

Location contact

Gaku Nakazawa, MD, PhD

CONTACT

Kuniaki Takahashi, MD, PhD

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No aspirin (Prasugurel monotherapy)

Drug

12-month prasugrel monotherapy

Other names: Experimental arm

12-month DAPT

Drug

12-month dual antiplatelet therapy with prasugrel and aspirin

Other names: Reference arm

Primary outcomes

  1. Major adverse cardiovascular events

    Time frame: 12 months

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

Secondary outcomes

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

    Time frame: 12 months

    Type 3 or 5 bleeding defined by BARC criteria

  2. All-cause death

    Time frame: 12 months

    Death from any cause

  3. Cardiovascular death

    Time frame: 12 months

    Death from cardiovascular cause

  4. Non-cardiovascular death

    Time frame: 12 months

    Death from non-cardiovascular cause

  5. Myocardial infarction (Periprocedual/ Spontaneous)

    Time frame: 12 months

    Defined by the Academic Research Consortium (ARC)-2

  6. Stroke (Ischemic/ Haemorrhagic)

    Time frame: 12 months

    Including both ischemic and haemorrhagic stroke

  7. Ischemic stroke

    Time frame: 12 months

    Ischemic stroke with symptom lasting over 24 hours

  8. Hemorrhagic stroke

    Time frame: 12 months

    Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma

  9. Stent thrombosis

    Time frame: 12 months

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

  10. Target lesion failure

    Time frame: 12 months

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

  11. Target vessel failure

    Time frame: 12 months

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

  12. Patient-Oriented Composite Endpoint

    Time frame: 12 months

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

  13. Any target lesion revascularization

    Time frame: 12 months

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

  14. Clinically-driven target lesion revascularization

    Time frame: 12 months

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

  15. Non-target lesion revascularization

    Time frame: 12 months

    Revascularization to non-target lesions regardless PCI or CABG

  16. Coronary artery bypass grafting

    Time frame: 12 months

    Any coronary artery bypass grafting

  17. Any target vessel revascularization

    Time frame: 12 months

    Revascularization to the target vessel

  18. Any coronary revascularization

    Time frame: 12 months

    Revascularization regardless of PCI or CABG

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

    Time frame: 12 months

    Type 2 bleeding defined by BARC criteria

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

    Time frame: 12 months

    Type 3 bleeding defined by BARC criteria

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

    Time frame: 12 months

    Type 4 bleeding defined by BARC criteria

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

    Time frame: 12 months

    Type 5 bleeding defined by BARC criteria

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

    Time frame: 12 months

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

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

    Time frame: 12 months

    Major bleeding defined by TIMI criteria

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

    Time frame: 12 months

    Minor bleeding defined by TIMI criteria

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

    Time frame: 12 months

    Major or minor defined by TIMI criteria

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

    Time frame: 12 months

    Severe bleeding defined by GUSTO criteria

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

    Time frame: 12 months

    Moderate bleeding defined by GUSTO criteria

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

    Time frame: 12 months

    Moderate or severe bleeding defined by GUSTO criteria

  30. Intracranial bleeding

    Time frame: 12 months

    Intracranial bleeding regardless of spontaneous or trauma

  31. Gastrointestinal bleeding

    Time frame: 12 months

    Bleeding from gastrointestinal tract regardless of severity

  32. Gastrointestinal complaints

    Time frame: 12 months

    Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints

Study contacts

Contact information is provided by the study sponsor or research team.

Kuniaki Takahashi, MD, PhD

CONTACT

[email protected]

+81-72-366-0221

Sponsors and collaborators

Lead sponsor

Kindai University

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Acronym: PREMIUM

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Feb 2, 2023
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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