NCT02075125|TerminatedPhase 3ResultsDMC
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Comparison of Prasugrel and Ticagrelor Antiplatelet Effects in Korean Patients Presenting With ST-segment Elevation Myocardial Infarction
Sponsor study identifier
interventional
39
1 country
1
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)To compare efficacy and safety of prasugrel and ticagrelor in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
February 20, 2014
Actual (reported)March 3, 2014
Actual (reported)April 2015
Actual (reported)April 2015
Actual (reported)February 1, 2016
Actual (reported)Number of Participants With High Platelet Reactivity
Platelet reactivity were measured by VerifyNow (volumetrics accuretic，San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. High platelet reactivity (HPR) is defined as the result of P2Y12 reaction units (PRU) \>235 and platelet reactivity index (PRI) \>50%.
48 hours after loading dose of study drug
Major Adverse Cardiac and Cerebrovascular Events
30 days
Bleeding Event
30 days
Adverse Drug Reaction
30 days
Pre-procedure P2Y12 Reaction Units (PRU)
Baseline
Number of Participants With Low Platelet Reactivity
48 hours after loading dose of study drug
Prasugrel 60 mg as loading dose and followed by 10 mg/day as maintenance dose
Ticagrelor 180 mg as loading dose and followed by 90 mg twice a day as maintenance dose
Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
DongA University Hospital
Busan, 602-715, South Korea
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.
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.
For the present single-center pilot study, the small sample size was a major limitation, and as such was insufficiently powered to assess safety.
Moo Hyun Kim, M.D.
Dong-A University Hospital, Busan, Republic of Korea
39 participants (actual enrollment reported by the registry).
First Submitted
February 20, 2014
First Posted
March 3, 2014
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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.
Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)Last Updated
August 18, 2017
Results First Posted
February 1, 2016
Record last verified: 2017-07
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Source: ClinicalTrials.gov.
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