Prasugrel Switching Study in Patients With Acute Coronary Syndrome (ACS) Who Underwent Percutaneous Coronary Intervention (PCI)

Study Overview
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Brief Summary
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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.

Official Title
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Phase IV, Non-comparative, Open Label, Multicenter, 28-Week Switching Study of Prasugrel Maintenance Dose From Clopidogrel in Patients With Acute Coronary Syndrome (ACS) Who Underwent a Percutaneous Coronary Intervention (PCI) in Taiwan

Conditions
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Acute Coronary Syndrome (ACS)

Intervention / Treatment
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* Drug: Prasugrel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prasugrel<br>Participants with ACS who underwent PCI, and were previously taking clopidogrel, receive a maintenance dose (MD) of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS underwent PCI) | Drug: Prasugrel<br>* Prasugrel, oral tablets, containing 3.75 mg per tablet<br>* Other names: Efient®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline to Week 4 in P2Y12 Reaction Units During Period 1 | The mean change in the P2Y12 reaction unit value assessed from baseline to the end of the 4-week maintenance dose treatment period, after switching from clopidogrel maintenance dose to prasugrel maintenance dose was analyzed with a paired t-test model. Mean changes (including standard deviations) are presented. | Baseline up to Week 4 post-maintenance dose prasugrel treatment period | 
| Number of Participants With Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding Events During Period 2 | All safety events were assessed in the overall Safety Population, regardless of the study period. The incidence of major bleeding events (defined as non-coronary artery bypass grafting [CABG] thrombolysis in myocardial infarction (TIMI) major) after 28 maintenance dose treatment weeks (optional maximum 12-month P2Y12 inhibitor treatment after ACS participants underwent PCI) are reported. Non-CABG TIMI major bleeding was defined as any intracranial bleeding (excluding microhemorrhages less than 10 millimeter evident only on gradient-echo magnetic resonance imaging); clinically overt signs of hemorrhage associated with a drop in hemoglobin of greater than or equal to 5 g/dL; and fatal bleeding (bleeding that directly results in death within 7 days) | End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With High On-Treatment Platelet Reactivity (HTPR) During Period 1 | High On-Treatment Platelet Reactivity (HTPR) was defined as PRU >235. | Baseline up to Week 4 post-maintenance dose prasugrel treatment period | 
| Mean Percentage Change From Baseline to Week 4 in Platelet Inhibition During Period 1 | The mean percentage change in platelet inhibition at the end of the 4-week maintenance dose prasugrel treatment period, after switching from clopidogrel maintenance dose to prasugrel maintenance dose is reported. | Baseline up to Week 4 post-maintenance dose prasugrel treatment period | 
| Number of Participants With Adverse Events of Special Interest During Period 1 | Adverse events of special interest were defined as major and minor bleeding events, clinically relevant bleeding events, and any major adverse cardiovascular events (MACE). Non-CABG TIMI major bleeding was defined as any intracranial bleeding (excluding microhemorrhages less than 10 millimeter evident only on gradient-echo magnetic resonance imaging); clinically overt signs of hemorrhage associated with a drop in hemoglobin of greater than or equal to 5 g/dL; and fatal bleeding (bleeding that directly results in death within 7 days). Non-CABG TIMI minor bleeding was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to less than 5 g/dL. | Baseline up to Week 4 post-maintenance dose prasugrel treatment period | 
| Number of Participants With Adverse Events of Special Interest During Period 2 | All safety events were assessed in the overall Safety Population, regardless of the study period. Adverse events of special interest were defined as major and minor bleeding events, clinically relevant bleeding events, and any major adverse cardiovascular events (MACE). Non-CABG TIMI major bleeding was defined as any intracranial bleeding (excluding microhemorrhages less than 10 millimeter evident only on gradient-echo magnetic resonance imaging); clinically overt signs of hemorrhage associated with a drop in hemoglobin of greater than or equal to 5 g/dL; and fatal bleeding (bleeding that directly results in death within 7 days). Non-CABG TIMI minor bleeding was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to less than 5 g/dL. | End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Coronary Intervention (PCI), ST elevation myocardial infarction (STEMI), Non-ST elevation myocardial infarction [NSTEMI], Unstable angina (UA), Prasugrel, ACS-PCI