NCT05709626 PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction
| NCT ID | NCT05709626 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Kindai University |
| Condition | ST-segment Elevation Myocardial Infarction (STEMI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,258 participants |
| Start Date | 2023-02-28 |
| Primary Completion | 2025-01-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,258 participants in total. It began in 2023-02-28 with a primary completion date of 2025-01-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Gaku Nakazawa, MD, PhD
PRINCIPAL INVESTIGATOR
Kindai University Faculty of Medicine
Frequently Asked Questions
Who can join the NCT05709626 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ST-segment Elevation Myocardial Infarction (STEMI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05709626 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05709626 currently recruiting?
Yes, NCT05709626 is actively recruiting participants. Contact the research team at kuniaki.t.0125@gmail.com for enrollment information.
Where is the NCT05709626 trial being conducted?
This trial is being conducted at Sayama, Japan.
Who is sponsoring the NCT05709626 clinical trial?
NCT05709626 is sponsored by Kindai University. The principal investigator is Gaku Nakazawa, MD, PhD at Kindai University Faculty of Medicine. The trial plans to enroll 2,258 participants.