Prasugrel Monotherapy Compared to 12-Month Dual Antiplatelet Therapy in Patients with ST-Elevation Myocardial Infarction Using Platinum-Chromium Everolimus Eluting Stent
Led by Kindai University · Updated on 2023-03-01
2258
Participants Needed
1
Research Sites
156 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of prasugrel monotherapy without aspirin compared to 12-month dual antiplatelet therapy DAPT in patients with ST-segment Elevation Myocardial Infarction STEMI treated with a platinum-chrome everolimus-eluting stent PtCr-EES, SYNERGYTM. The study aims to determine if prasugrel alone is not worse than standard DAPT in preventing major cardiovascular events within 12 months after primary percutaneous coronary intervention PCI.
Participants will be assigned to one of two groups one receiving prasugrel monotherapy starting before PCI, and the other receiving both prasugrel and aspirin as dual therapy for 12 months before PCI. This phase 4 trial compares these two antiplatelet strategies to assess their impact on cardiovascular outcomes and bleeding risks.
During the study, participants will be monitored for major adverse cardiovascular events over 12 months. Researchers will assess various outcomes including types of bleeding, death causes, myocardial infarction, stroke, stent thrombosis, and need for additional coronary procedures. Safety and efficacy data will be collected throughout to evaluate the treatments under study, with a total participation period of at least one year.
CONDITIONS
Brief Title
PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction
Research Team
K
Kuniaki Takahashi, MD, PhD
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Patients scheduled for primary PCI with everolimus-eluting stent (PtCr-EES, SYNERGYTM)
Patients diagnosed with ST-segment Elevation Myocardial Infarction (STEMI)
Patients who can continue dual antiplatelet therapy with aspirin and a P2Y12 inhibitor for 12 months
You will not qualify if you...
Patients taking anticoagulant medications
Patients under 18 years old
Patients with less than 1 year prognosis
Patients participating in other intervention studies
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants receive either prasugrel monotherapy or dual antiplatelet therapy with prasugrel and aspirin after primary percutaneous coronary intervention (PCI).
Visits scheduled throughout the 12-month treatment period
Follow-up
Duration - Up to 12 months after primary PCI
Participants are monitored for major cardiovascular events and bleeding outcomes following the treatment period.
Visits may occur to assess outcomes up to 12 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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.
Kuniaki Takahashi, Ken Kozuma, Yoshihiro Morino...