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ST-Segment Elevation Myocardial InfarctionPhase 3NCT02075125

Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction

A Phase 3 study testing Prasugrel 60 mg and Ticagrelor 180 mg in people with ST-Segment Elevation Myocardial Infarction, run by Dong-A University at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 80 years
What is being tested?
Prasugrel 60 mg and Ticagrelor 180 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteSouth Korea
Study dates
Jan 2014to Apr 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 9Show fewer
  • Severe hepatic dysfunction (serum liver enzyme or bilirubin>3 times normal limit)
  • Sever chronic obstructive pulmonary disease (COPD) or bradycardia
  • Body weight < 50 kg

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • DongA University Hospital

    Busan, 602-715

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
Prasugrel 60 mg, Ticagrelor 180 mg
Keywords
Korea, Platelet inhibition, Prasugrel, Ticagrelor, ST-segment elevation myocardial infarction
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prasugrel 60 mgDrug

    Also called Effient 60 mg

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

  • Ticagrelor 180 mgDrug

    Also called Brilinta 180 mg

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

Study groups in NCT02075125
Study groupRoleWhat they receive
Prasugrel 60 mgExperimentalPrasugrel 60 mg as loading dose and followed by 10 mg/day as maintenance dose
Receives: Drug: Prasugrel 60 mg
Ticagrelor 180 mgExperimentalTicagrelor 180 mg as loading dose and followed by 90 mg twice a day as maintenance dose
Receives: Drug: Ticagrelor 180 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%.

    Measured: 48 hours after loading dose of study drug

Secondary outcomes (6)

  1. Major Adverse Cardiac and Cerebrovascular Events

    Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30.

    Measured: 30 days

  2. Bleeding Event

    Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria.

    Measured: 30 days

  3. Adverse Drug Reaction

    Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention.

    Measured: 30 days

  4. 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).

    Measured: Baseline

  5. 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.

    Measured: 48 hours after loading dose of study drug

  6. 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).

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionApr 2015
  4. Study completionApr 2015

Why it stopped: Enrolling participants has halted prematurely and will not resume

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02075125
Sponsor's protocol ID
PANTASTIC
Status last verified
Jul 2017
First submitted
20 Feb 2014
Last updated
18 Aug 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23500251

  • 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.

    PubMed 23169985

  • 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.

    PubMed 25959558

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prasugrel 60 mg and Ticagrelor 180 mg in people with ST-Segment Elevation Myocardial Infarction, run by Dong-A University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With High Platelet Reactivity (time frame: 48 hours after loading dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02075125, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.

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