Clinical trial NCT02075125: Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction
Official title: Comparison of Prasugrel and Ticagrelor Antiplatelet Effects in Korean Patients Presenting With ST-segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: ST-Segment Elevation Myocardial Infarction
Keywords: Korea
Platelet inhibition
Prasugrel
Ticagrelor
ST-segment elevation myocardial infarction
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare efficacy and safety of prasugrel and ticagrelor in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Detailed description: Prasugrel and ticagrelor are recommended in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Both prasugrel and ticagrelor show more rapid and potent antiplatelet effect compared with clopidogrel. However, previous report comparing the efficacy and safety of prasugrel and ticagrelor in patients with STEMI of East Asian ethnicity is lacking. Therefore, the aim of this study is to compare the antiplatelet efficacy and safety using laboratory platelet function tests and clinical outcomes in patients with STEMI treated with either prasugrel or ticagrelor.

Eligibility criteria: Inclusion Criteria:

* Patients with ST-segment elevation myocardial infarction
* Undergoing primary percutaneous coronary intervention
* Aged between 20 and 80 years

Exclusion Criteria:

* Previous administration of any antagonist of the platelet adenosine diphosphate (ADP) P2Y12 receptor (clopidogrel, prasugrel or ticagrelor)
* History of stroke or transient ischemic attack
* Previous gastrointestinal bleeding within 6 months, bleeding diathesis, platelet count \< 100,000/mm3 or hemoglobin \< 10 g/dl
* Chronic oral anticoagulation treatment
* Contraindication to the antiplatelet treatment
* Severe renal insufficiency (serum creatine\>2.5 mg/dl)
* Severe hepatic dysfunction (serum liver enzyme or bilirubin\>3 times normal limit)
* Sever chronic obstructive pulmonary disease (COPD) or bradycardia
* Body weight \< 50 kg

Primary outcomes:
measure: Number of Participants With High Platelet Reactivity
timeFrame: 48 hours after loading dose of study drug
Secondary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Events
timeFrame: 30 days
measure: Bleeding Event
timeFrame: 30 days
measure: Adverse Drug Reaction
timeFrame: 30 days
measure: Pre-procedure P2Y12 Reaction Units (PRU)
timeFrame: Baseline
measure: Number of Participants With Low Platelet Reactivity
timeFrame: 48 hours after loading dose of study drug
measure: Pre-procedure Platelet Reactivity Index (PRI)
timeFrame: Baseline
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: DongA University Hospital
Study officials:
affiliation: Dong-A University Hospital, Busan, Republic of Korea
name: Moo Hyun Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parodi G, Valenti R, Bellandi B, Migliorini A, Marcucci R, Comito V, Carrabba N, Santini A, Gensini GF, Abbate R, Antoniucci D. Comparison of prasugrel and ticagrelor loading doses in ST-segment elevation myocardial infarction patients: RAPID (Rapid Activity of Platelet Inhibitor Drugs) primary PCI study. J Am Coll Cardiol. 2013 Apr 16;61(15):1601-6. doi: 10.1016/j.jacc.2013.01.024. Epub 2013 Mar 22.
citation: Alexopoulos D, Xanthopoulou I, Gkizas V, Kassimis G, Theodoropoulos KC, Makris G, Koutsogiannis N, Damelou A, Tsigkas G, Davlouros P, Hahalis G. Randomized assessment of ticagrelor versus prasugrel antiplatelet effects in patients with ST-segment-elevation myocardial infarction. Circ Cardiovasc Interv. 2012 Dec;5(6):797-804. doi: 10.1161/CIRCINTERVENTIONS.112.972323. Epub 2012 Nov 20.
citation: Lee YS, Jin CD, Kim MH, Guo LZ, Cho YR, Park K, Park JS, Park TH, Kim YD. Comparison of Prasugrel and Ticagrelor Antiplatelet Effects in Korean Patients Presenting With ST-Segment Elevation Myocardial Infarction. Circ J. 2015;79(6):1248-54. doi: 10.1253/circj.CJ-15-0270. Epub 2015 May 11.