Prasugrel Monotherapy Following PrImary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction

Prasugrel Monotherapy Following PrImary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction - PREMIUM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs052220145

Enrollment

2258

Registered

2023-01-05

Start date

2023-04-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST-Elevation Myocardial Infarction

Interventions

Group A: Randomized prior to PCI with SYNERGY to non-asupirin (prasugrel alone) for 12 months Group B: Randomized prior to PCI with SYNERGY to dual antiplatelet therapy (aspirin + prasugrel)

No DAPT after PCI with DES

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients scheduled for Primary PCI with everolimus-eluting stent (PtCr-EES, SYNERGY) STEMI patients Patients who can continue dual antiplatelet therapy with aspirin and a P2Y12 inhibitor for 12 months

Exclusion criteria

Exclusion criteria: Patients taking anticoagulants Under 18 years old Prognosis less than 1 year Participated in other intervention studies

Design outcomes

Primary

Measure	Time frame
the composite primary cardiovascular endpoint consisting of all-cause death/myocardial infarction/stroke at 12 months after stent implantation	—

Secondary

Measure	Time frame
The major secondary endpoint of this study is as follows: 12 months after enrollment Major bleeding (BARC 3 or 5 bleeding) The secondary endpoints of this study are as follows: They will be assessed at 12 months after enrollment. All-cause death Cardiovascular death Non-cardiovascular death MI (target-vessel, non-target vessel) Stroke Ischemic stroke Hemorrhagic stroke ST (ARC) TLF TVF POCE Any TLR Clinically driven TLR Non TLR CABG Any TVR Any coronary revascularization Bleeding complications BARC 2 BARC 3 BARC 4 BARC 5 BARC 2/3/5 TIMI major TIMI minor TIMI major/minor GUSTO severe GUSTO moderate GUSTO moderate/severe Intracranial bleeding Gastrointestinal bleeding Gastrointestinal complaints	—

Measure

Time frame

The major secondary endpoint of this study is as follows: 12 months after enrollment Major bleeding (BARC 3 or 5 bleeding) The secondary endpoints of this study are as follows: They will be assessed at 12 months after enrollment. All-cause death Cardiovascular death Non-cardiovascular death MI (target-vessel, non-target vessel) Stroke Ischemic stroke Hemorrhagic stroke ST (ARC) TLF TVF POCE Any TLR Clinically driven TLR Non TLR CABG Any TVR Any coronary revascularization Bleeding complications BARC 2 BARC 3 BARC 4 BARC 5 BARC 2/3/5 TIMI major TIMI minor TIMI major/minor GUSTO severe GUSTO moderate GUSTO moderate/severe Intracranial bleeding Gastrointestinal bleeding Gastrointestinal complaints

—

Contacts

Public ContactKuniaki Takahashi

Kindai University Hospital

kuniaki.t.0125@gmail.com+81-72-288-7222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026