NCT02808767

Brief Summary

This study evaluates the efficacy of Prasugrel and Ticagrelor in the treatment of acute myocardial infarction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,226

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

3.3 years

First QC Date

June 12, 2016

Last Update Submit

August 10, 2017

Conditions

Myocardial InfarctionAngioplasty, Balloon, CoronaryPlatelet Aggregation Inhibitors

Keywords

Acute myocardial infarctionPrimary coronary interventionAntiplatelet therapy

Outcome Measures

Primary Outcomes (1)

  • Composite primary outcome measure consisting of Death / Re-infarction / Stroke / Serious bleeding requiring transfusion or prolonged hospitalization / Urgent Target Vessel Revascularization.

    Definitions: Death defined as summary of death from any cause. Re-infarcion defined according to the Third Universal Definition of Myocardial Infarction. Stroke defined as the rapid onset of new neurological deficit caused by an ischemic or hemorrhagic central nervous system event with symptoms that lasted at least 24 hours after onset or leading to death. Urgent Target Vessel Revascularization defined as a new emergent/urgent revascularization of the vessel dilated at the initial procedure driven by recurrent signs of ischemia occurring after completion of initial PCI. Units: The percentage of randomized patients is the total number of randomized patients experiencing Death / Re-infarction / Stroke / Serious bleeding requiring transfusion or prolonged hospitalization / Urgent Target Vessel Revascularization divided by number of randomized patients in the treatment arm multiplied by 100. Primary endpoint is adjudicated by the Independent Control committee

    Within 7 days after Randomization.

Secondary Outcomes (3)

  • Composite secondary outcome measure consisting of Cadiovascular death / Non-fatal myocardial infarction / Stroke.

    Within 30 days and one year after Randomization.

  • Stent thrombosis.

    Within 30 days and one year after Randomization.

  • Occurence of bleeding according to the TIMI and BARC criteria.

    Within 30 days and one year after Randomization.

Other Outcomes (1)

  • Composite outcome measure consisting of Cadiovascular death / Non-fatal myocardial infarction / Stroke in patients with Killip III/IV.

    Within 7 days after Randomization.

Study Arms (2)

Patients treated with Prasugrel

EXPERIMENTAL

Prasugrel Loading dose: 60 mg Maintenance dose: 10 mg once-daily; patients \>75 years of age or \< 60 kg of weight receive a maintenance dose of 5 mg o.d.

Drug: Prasugrel

Patients treated with ticagrelor

EXPERIMENTAL

Ticagrelor Loading dose: 180 mg Maintenance dose: 90mg twice-daily

Drug: Ticagrelor

Interventions

PrasugrelDRUG

Prasugrel 60 mg loading dose and 10mg/5mg once daily maintenance dose

Also known as: Efient
Patients treated with Prasugrel
TicagrelorDRUG

Ticagrelor 180 mg loading dose and 90 mg twice daily maintenance dose

Also known as: Brilique
Patients treated with ticagrelor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute myocardial infarction (\> 1mm ST elevation in at least 2 related leads or ST depression \> 2mm in 3 leads or new BBB) with an indication to emergent (within 120 minut from admission to the PCI center) coronary angiography and PCI,
  • Signed informed consent.

You may not qualify if:

  • History of stroke,
  • Serious bleeding within last 6 months,
  • Indication to an oral anticoagulation (e.g. atrial fibrillation, artificial valve, thromboembolism etc...)
  • Use of ≥ 300 mg of clopidogrel or another antiplatelet agent (except of aspirin and lower dose of clopidogrel) before randomization,
  • Low body weight (\<60 kg) in an older patient (\>75 years of age),
  • Moderate or severe liver dysfunction,
  • Ongoing therapy with a strong CYP3A4 inhibitor (e.g. ketoconazole, clarythromycine, nefazodone, ritonavir, atazanavit),
  • Hypersensitivity to prasugrel or ticagrelor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Hospital Kralovske Vinohrady

Prague, 10034, Czechia

Location

Related Publications (2)

  • Motovska Z, Hlinomaz O, Miklik R, Hromadka M, Varvarovsky I, Dusek J, Knot J, Jarkovsky J, Kala P, Rokyta R, Tousek F, Kramarikova P, Majtan B, Simek S, Branny M, Mrozek J, Cervinka P, Ostransky J, Widimsky P; PRAGUE-18 Study Group. Prasugrel Versus Ticagrelor in Patients With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention: Multicenter Randomized PRAGUE-18 Study. Circulation. 2016 Nov 22;134(21):1603-1612. doi: 10.1161/CIRCULATIONAHA.116.024823. Epub 2016 Aug 30.

    PMID: 27576777BACKGROUND

  • Motovska Z, Hlinomaz O, Kala P, Hromadka M, Knot J, Varvarovsky I, Dusek J, Jarkovsky J, Miklik R, Rokyta R, Tousek F, Kramarikova P, Svoboda M, Majtan B, Simek S, Branny M, Mrozek J, Cervinka P, Ostransky J, Widimsky P; PRAGUE-18 Study Group. 1-Year Outcomes of Patients Undergoing Primary Angioplasty for Myocardial Infarction Treated With Prasugrel Versus Ticagrelor. J Am Coll Cardiol. 2018 Jan 30;71(4):371-381. doi: 10.1016/j.jacc.2017.11.008. Epub 2017 Nov 14.

    PMID: 29154813DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Prasugrel HydrochlorideTicagrelor

Condition Hierarchy (Ancestors)

Myocardial 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

Study Officials

  • Zuzana Motovska, MD PhD

    University Hospital Kralovske Vinohrady, Prague, Czech Republic

    PRINCIPAL INVESTIGATOR

  • Petr Widimsky, Prof MD DrSc

    University Hospital Kralovske Vinohrady, Prague, Czech Republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Accociate Professor

Study Record Dates

First Submitted

June 12, 2016

First Posted

June 22, 2016

Study Start

January 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2017

Last Updated

August 11, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)