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Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT02075125
Recruitment Status : Terminated (Enrolling participants has halted prematurely and will not resume)
First Posted : March 3, 2014
Results First Posted : February 1, 2016
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Moo Hyun Kim, Dong-A University

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

Condition or disease Intervention/treatment Phase
ST-Segment Elevation Myocardial Infarction Drug: Prasugrel 60 mg Drug: Ticagrelor 180 mg Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Prasugrel and Ticagrelor Antiplatelet Effects in Korean Patients Presenting With ST-segment Elevation Myocardial Infarction
Study Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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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 Name: 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 Name: Brilinta 180 mg


Outcome Measures
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Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Adverse Drug Reaction [ Time Frame: 30 days ]
    Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention.

  4. 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).

  5. 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.

  6. 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).


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075125


Locations
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Korea, Republic of
DongA University Hospital
Busan, Korea, Republic of, 602-715
Sponsors and Collaborators
Dong-A University
Investigators
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Principal Investigator: Moo Hyun Kim, M.D. Dong-A University Hospital, Busan, Republic of Korea
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Moo Hyun Kim, M.D. Director, Global Clinical Trial Center. Professor, Dept. of Cardiology Dong-A Unicersity Hospital, Dong-A University
ClinicalTrials.gov Identifier: NCT02075125    
Other Study ID Numbers: PANTASTIC
First Posted: March 3, 2014    Key Record Dates
Results First Posted: February 1, 2016
Last Update Posted: August 18, 2017
Last Verified: July 2017
Keywords provided by Moo Hyun Kim, Dong-A University:
Korea
Platelet inhibition
Prasugrel
Ticagrelor
ST-segment elevation myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Ticagrelor
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs