Actively Recruiting
Led by Kindai University · Updated on 2023-03-01
2258
Participants Needed
1
Research Sites
156 weeks
Total Duration
K
Kindai University
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
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
PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Kindai University Faculty of Medicine
Sayama, Osaka, Japan, 589-8511
Actively Recruiting
K
Kuniaki Takahashi, MD, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Kuniaki Takahashi, Ken Kozuma, Yoshihiro Morino...
https://pubmed.ncbi.nlm.nih.gov/41436299