NCT05709626

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,258

participants targeted

Target at P75+ for phase_4

Timeline
20mo left

Started Feb 2023

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Feb 2023Jan 2028

First Submitted

Initial submission to the registry

January 19, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2028

Expected
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1.9 years

First QC Date

January 19, 2023

Last Update Submit

February 28, 2023

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Keywords

Acute Coronary SyndromeDual AntiPlatelet TherapyDrug Eluting StentPercutaneous Coronary InterventionST-elevation myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular events

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

    12 months

Secondary Outcomes (32)

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

    12 months

  • All-cause death

    12 months

  • Cardiovascular death

    12 months

  • Non-cardiovascular death

    12 months

  • Myocardial infarction (Periprocedual/ Spontaneous)

    12 months

  • +27 more secondary outcomes

Study Arms (2)

No aspirin (Prasugrel monotherapy)

ACTIVE COMPARATOR

To start prasugrel monotherapy before primary percutaneous coronary intervention (PCI).

Drug: No aspirin (Prasugurel monotherapy)

12-month DAPT

ACTIVE COMPARATOR

To start dual antiplatelet therapy with prasugrel and aspirin for 12 months before primary percutaneous coronary intervention (PCI).

Drug: 12-month DAPT

Interventions

No aspirin (Prasugurel monotherapy)DRUG

12-month prasugrel monotherapy

Also known as: Experimental arm
No aspirin (Prasugrel monotherapy)
12-month DAPTDRUG

12-month dual antiplatelet therapy with prasugrel and aspirin

Also known as: Reference arm
12-month DAPT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kindai University Faculty of Medicine

Sayama, Osaka, 589-8511, Japan

RECRUITING

Related Publications (1)

  • 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. 2025 Dec 11:S1553-8389(25)00611-6. doi: 10.1016/j.carrev.2025.12.007. Online ahead of print.

    PMID: 41436299DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionAcute Coronary Syndrome

Interventions

N-acetyl-S-(alpha-methyl-4-(2-methylpropyl)benzeneacetyl)cysteine 4-(nitrooxy)butyl ester2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Gaku Nakazawa, MD, PhD

    Kindai University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuniaki Takahashi, MD, PhD

CONTACT

+81-72-366-0221kuniaki.t.0125@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2023

First Posted

February 2, 2023

Study Start

February 28, 2023

Primary Completion

January 4, 2025

Study Completion (Estimated)

January 4, 2028

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)