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Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction

Primary Purpose

ST-Segment Elevation Myocardial Infarction

Status
Terminated
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Prasugrel 60 mg
Ticagrelor 180 mg
Sponsored by
Dong-A University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-Segment Elevation Myocardial Infarction focused on measuring Korea, Platelet inhibition, Prasugrel, Ticagrelor, ST-segment elevation myocardial infarction

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DongA University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Prasugrel 60 mg

Ticagrelor 180 mg

Arm Description

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

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

Major Adverse Cardiac and Cerebrovascular Events
Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30.
Bleeding Event
Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria.
Adverse Drug Reaction
Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention.
Pre-procedure P2Y12 Reaction Units (PRU)
Platelet reactivity was measured using VerifyNow (volumetrics accuretic, San Diego, California, USA). Platelet reactivity values were presented as P2Y12 reaction units (PRU).
Number of Participants With Low Platelet Reactivity
Platelet reactivity were measured using 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. Low platelet reactivity (LPR) is defined as the result of P2Y12 reaction units (PRU) <85 and platelet reactivity index (PRI)<16%. The PRU value for LPR, 18 patients were in prasugrel groups and 19 patients in ticagrelor groups, regarding the PRI value for LPR, 16 patients were in each groups.
Pre-procedure Platelet Reactivity Index (PRI)
Platelet reactivity was measured using vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay. Platelet reactivity values were presented as platelet reactivity index (PRI).

Full Information

First Posted
February 20, 2014
Last Updated
July 11, 2017
Sponsor
Dong-A University
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1. Study Identification

Unique Protocol Identification Number
NCT02075125
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Enrolling participants has halted prematurely and will not resume
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dong-A University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-Segment Elevation Myocardial Infarction
Keywords
Korea, Platelet inhibition, Prasugrel, Ticagrelor, ST-segment elevation myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prasugrel 60 mg
Arm Type
Experimental
Arm Description
Prasugrel 60 mg as loading dose and followed by 10 mg/day as maintenance dose
Arm Title
Ticagrelor 180 mg
Arm Type
Experimental
Arm Description
Ticagrelor 180 mg as loading dose and followed by 90 mg twice a day as maintenance dose
Intervention Type
Drug
Intervention Name(s)
Prasugrel 60 mg
Other Intervention Name(s)
Effient 60 mg
Intervention Description
Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
Intervention Type
Drug
Intervention Name(s)
Ticagrelor 180 mg
Other Intervention Name(s)
Brilinta 180 mg
Intervention Description
Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
Primary Outcome Measure Information:
Title
Number of Participants With High Platelet Reactivity
Description
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%.
Time Frame
48 hours after loading dose of study drug
Secondary Outcome Measure Information:
Title
Major Adverse Cardiac and Cerebrovascular Events
Description
Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30.
Time Frame
30 days
Title
Bleeding Event
Description
Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria.
Time Frame
30 days
Title
Adverse Drug Reaction
Description
Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention.
Time Frame
30 days
Title
Pre-procedure P2Y12 Reaction Units (PRU)
Description
Platelet reactivity was measured using VerifyNow (volumetrics accuretic, San Diego, California, USA). Platelet reactivity values were presented as P2Y12 reaction units (PRU).
Time Frame
Baseline
Title
Number of Participants With Low Platelet Reactivity
Description
Platelet reactivity were measured using 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. Low platelet reactivity (LPR) is defined as the result of P2Y12 reaction units (PRU) <85 and platelet reactivity index (PRI)<16%. The PRU value for LPR, 18 patients were in prasugrel groups and 19 patients in ticagrelor groups, regarding the PRI value for LPR, 16 patients were in each groups.
Time Frame
48 hours after loading dose of study drug
Title
Pre-procedure Platelet Reactivity Index (PRI)
Description
Platelet reactivity was measured using vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay. Platelet reactivity values were presented as platelet reactivity index (PRI).
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moo Hyun Kim, M.D.
Organizational Affiliation
Dong-A University Hospital, Busan, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
DongA University Hospital
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23500251
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.
Results Reference
background
PubMed Identifier
23169985
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.
Results Reference
background
PubMed Identifier
25959558
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.
Results Reference
derived

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Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction

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