Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction

July 11, 2017 updated by: Moo Hyun Kim, Dong-A University

Comparison of Prasugrel and Ticagrelor Antiplatelet Effects in Korean Patients Presenting With ST-segment Elevation Myocardial Infarction

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prasugrel 60 mg
Prasugrel 60 mg as loading dose and followed by 10 mg/day as maintenance dose
Drug: Prasugrel 60 mg
Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
Other Names:
  • Effient 60 mg
Experimental: Ticagrelor 180 mg
Ticagrelor 180 mg as loading dose and followed by 90 mg twice a day as maintenance dose
Drug: Ticagrelor 180 mg
Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
Other Names:
  • Brilinta 180 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With High Platelet Reactivity
Time Frame: 48 hours after loading dose of study drug
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac and Cerebrovascular Events
Time Frame: 30 days
Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30.
30 days
Bleeding Event
Time Frame: 30 days
Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria.
30 days
Adverse Drug Reaction
Time Frame: 30 days
Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention.
30 days
Pre-procedure P2Y12 Reaction Units (PRU)
Time Frame: Baseline
Platelet reactivity was measured using VerifyNow (volumetrics accuretic, San Diego, California, USA). Platelet reactivity values were presented as P2Y12 reaction units (PRU).
Baseline
Number of Participants With Low Platelet Reactivity
Time Frame: 48 hours after loading dose of study drug
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.
48 hours after loading dose of study drug
Pre-procedure Platelet Reactivity Index (PRI)
Time Frame: Baseline
Platelet reactivity was measured using vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay. Platelet reactivity values were presented as platelet reactivity index (PRI).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A University

Investigators

  • Principal Investigator: Moo Hyun Kim, M.D., Dong-A University Hospital, Busan, Republic of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

February 20, 2014

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Actual)

August 18, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANTASTIC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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