Evaluating prasugrel alone after heart intervention for heart attack patients
PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction
This study is testing if taking prasugrel alone after a heart procedure is safer and just as effective as taking it with aspirin for heart attack patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2258 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kindai University Academic / other |
| Locations | 1 site (Sayama, Osaka) |
| Trial ID | NCT05709626 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety of prasugrel monotherapy compared to a standard 12-month dual antiplatelet therapy (DAPT) in patients who have experienced a ST-elevation myocardial infarction (STEMI) and are undergoing primary percutaneous coronary intervention (PCI) with a specific type of stent. The research will focus on the incidence of major cardiovascular events over a 12-month period following the intervention. By comparing the outcomes of patients receiving prasugrel alone versus those receiving both prasugrel and aspirin, the study seeks to determine if monotherapy can reduce bleeding risks while maintaining efficacy. This trial builds on previous findings that suggest prasugrel may be more effective than clopidogrel in this context.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for primary PCI with an everolimus-eluting stent who have experienced a STEMI.
Not a fit: Patients taking anticoagulants, those under 18 years old, or individuals with a prognosis of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer alternative treatment for STEMI patients by reducing the risk of bleeding without compromising cardiovascular outcomes.
How similar studies have performed: Previous studies have shown promising results with P2Y12 inhibitor monotherapy, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sayama, Osaka
- Kindai University Faculty of Medicine — Sayama, Osaka, Japan (Recruiting)
Study contacts
- Principal investigator: Gaku Nakazawa, MD, PhD — Kindai University Faculty of Medicine
- Study coordinator: Kuniaki Takahashi, MD, PhD
- Email: kuniaki.t.0125@gmail.com
- Phone: +81-72-366-0221
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.