NCT02075125

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 1, 2016

Completed
Last Updated

August 18, 2017

Status Verified

July 1, 2017

Enrollment Period

1.2 years

First QC Date

February 20, 2014

Results QC Date

September 13, 2015

Last Update Submit

July 11, 2017

Conditions

ST-Segment Elevation Myocardial Infarction

Keywords

KoreaPlatelet inhibitionPrasugrelTicagrelorST-segment elevation myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Prasugrel 60 mg

EXPERIMENTAL

Prasugrel 60 mg as loading dose and followed by 10 mg/day as maintenance dose

Drug: Prasugrel 60 mg

Ticagrelor 180 mg

EXPERIMENTAL

Ticagrelor 180 mg as loading dose and followed by 90 mg twice a day as maintenance dose

Drug: Ticagrelor 180 mg

Interventions

Prasugrel 60 mgDRUG

Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.

Also known as: Effient 60 mg
Prasugrel 60 mg
Ticagrelor 180 mgDRUG

Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.

Also known as: Brilinta 180 mg
Ticagrelor 180 mg

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DongA University Hospital

Busan, 602-715, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 23500251BACKGROUND

  • 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.

    PMID: 23169985BACKGROUND

  • 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.

    PMID: 25959558DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Prasugrel HydrochlorideTicagrelor

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Limitations and Caveats

For the present single-center pilot study, the small sample size was a major limitation, and as such was insufficiently powered to assess safety.

Results Point of Contact

Title
Dr. Moo Hyun Kim; Director of Global Clinical Trial Center Dong-A University Hospital.
Organization
Department of Cardiology, College of Medicine, Dong-A University.
kimmh@dau.ac.kr
+82 (51) 240-2976

Study Officials

  • Moo Hyun Kim, M.D.

    Dong-A University Hospital, Busan, Republic of Korea

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Director, Global Clinical Trial Center. Professor, Dept. of Cardiology Dong-A Unicersity Hospital

Study Record Dates

First Submitted

February 20, 2014

First Posted

March 3, 2014

Study Start

January 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

August 18, 2017

Results First Posted

February 1, 2016

Record last verified: 2017-07

Locations

KR(1)