Clinical trial NCT03672097: Prasugrel Switching Study in Patients With Acute Coronary Syndrome (ACS) Who Underwent Percutaneous Coronary Intervention (PCI)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome (ACS)
Keywords: Percutaneous Coronary Intervention (PCI)
ST elevation myocardial infarction (STEMI)
Non-ST elevation myocardial infarction [NSTEMI]
Unstable angina (UA)
Prasugrel
ACS-PCI
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2018-09-14
Enrollment: 204
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Mean Change From Baseline to Week 4 in P2Y12 Reaction Units During Period 1
timeFrame: Baseline up to Week 4 post-maintenance dose prasugrel treatment period
measure: Number of Participants With Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding Events During Period 2
timeFrame: End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period
Secondary outcomes:
measure: Number of Participants With High On-Treatment Platelet Reactivity (HTPR) During Period 1
timeFrame: Baseline up to Week 4 post-maintenance dose prasugrel treatment period
measure: Mean Percentage Change From Baseline to Week 4 in Platelet Inhibition During Period 1
timeFrame: Baseline up to Week 4 post-maintenance dose prasugrel treatment period
measure: Number of Participants With Adverse Events of Special Interest During Period 1
timeFrame: Baseline up to Week 4 post-maintenance dose prasugrel treatment period
measure: Number of Participants With Adverse Events of Special Interest During Period 2
timeFrame: End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
Study officials:
affiliation: Daiichi Sankyo
name: Clinical Study Leader
role: STUDY_DIRECTOR
References:
citation: Liu PY, Su CH, Kuo FY, Lee WL, Wang YC, Lin WS, Chu PH, Lu TM, Lo PH, Lee CH, Lan WR, Huang CL, Tsukiyama S, Yang WC, Cheng LC, Rafael V, Nikolajsen C, Yin WH. Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy. Cardiovasc Interv Ther. 2022 Apr;37(2):269-278. doi: 10.1007/s12928-021-00771-w. Epub 2021 Apr 4.