Prasugrel Switching Study in Patients With Acute Coronary Syndrome (ACS) Who Underwent Percutaneous Coronary Intervention (PCI)
Condition: Acute Coronary Syndrome (ACS)
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Prasugrel
Intervention description: Prasugrel, oral tablets, containing 3.75 mg per tablet
Intervention MeSH terms: Prasugrel Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 204.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Percutaneous Coronary Intervention (PCI); ST elevation myocardial infarction (STEMI); Non-ST elevation myocardial infarction [NSTEMI]; Unstable angina (UA); Prasugrel; ACS-PCI

Summary:

      This Phase IV, multicenter trial is designed to assess the efficacy of prasugrel in
      preventing the formation of blood clots in Taiwanese patients with ACS who have been treated
      with PCI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is within the age limits and has signed informed consent

          -  Weighs at least 50 kg

          -  Had a previous diagnosis of ACS (UA, STEMI, or NSTEMI), underwent PCI, and received
             one of the following treatments:

               -  Clopidogrel MD of 75 mg and aspirin 81-100 mg for 2-8 weeks following clopidogrel
                  loading dose (LD) of 300 mg or 600 mg at the time of PCI

               -  Ticagrelor MD of 90 mg twice daily (BID) and aspirin 81-100 mg for 1-4 weeks and
                  switching to clopidogrel MD of 75 mg and aspirin 81-100 mg for 2-4 weeks
                  following ticagrelor LD of 180 mg at the time of PCI

               -  Clopidogrel MD 75 mg and aspirin 81-100 mg for 2-8 weeks following ticagrelor LD
                  of 180 mg at the time of PCI

               -  Or based on investigator's judgment with at least 2 weeks continued use of
                  clopidogrel MD and aspirin 81-100 mg per day before switching to prasugrel and
                  maximum 8 weeks P2Y12 inhibitors MD treatment (prasugrel is not allowed)

          -  Is willing and able to abide by the rules of the research unit and study restrictions

          -  If a woman of child-bearing potential, has a negative serum pregnancy test at
             screening

          -  Agrees to use at least one method of contraception during the study

        Exclusion Criteria:

          -  Has active bleeding, significant risk of hemorrhage, or unusual susceptibility to
             bleed

          -  Had previous hemorrhagic stroke at any time, or transient ischemic attack (TIA) or
             ischemic stroke within 3 months before the informed consent date

          -  Has known allergies or hypersensitivity to prasugrel, aspirin, or any of their
             excipients

          -  Has significant hypertension at screening or baseline assessment

          -  Has hemoglobin levels <10.5 g/dL or hematocrit levels <30%

          -  Has severe left ventricular systolic dysfunction, ejection fraction <30%

          -  Is currently undergoing hemodialysis

          -  Has evidence of severe hepatic disease or any of the following: serum alanine
             transaminase or aspartate transaminase ≥3 times the upper limit of normal (ULN); or
             bilirubin ≥2 times the ULN at screening

          -  Has any clinical laboratory result performed at screening that is determined to be
             detrimental to the patient or could compromise the study as determined the
             Investigator

          -  Has previously participated in this study or in another interventional trial that is
             not compatible with this study

          -  Has evidence of significant active neuropsychiatric disease, alcohol abuse or drug
             abuse as determined by the Investigator