Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction (PRAGUE-18)

August 10, 2017 updated by: Zuzana Motovska, Faculty Hospital Kralovske Vinohrady
This study evaluates the efficacy of Prasugrel and Ticagrelor in the treatment of acute myocardial infarction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study objectives:

  1. Compare the efficacy and safety of prasugrel and ticagrelor in acute myocardial infarction treated with emergent PCI.
  2. Assess the safety of switching to clopidogrel after remission of the acute phase of MI in patients for whom economic barriers do not allow to continue treatment with prasugrel or ticagrelor. All randomized patients with acute myocardial infarction have been treated with standard therapeutic procedures in accordance with the guidelines of European Society of Cardiology (ESC). Participation of patients in the study is not connected to any deviations from the ESC guidelines recommendations.

Study Type

Interventional

Enrollment (Actual)

1226

Phase

  • Phase 4

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

  • Czechia
      • Prague, Czechia, 10034
        • Faculty Hospital Kralovske Vinohrady

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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,
  2. Signed informed consent.

Exclusion Criteria:

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

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: Patients treated with Prasugrel
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
Prasugrel 60 mg loading dose and 10mg/5mg once daily maintenance dose
Other Names:
  • Efient
Experimental: Patients treated with ticagrelor
Ticagrelor Loading dose: 180 mg Maintenance dose: 90mg twice-daily
Drug: Ticagrelor
Ticagrelor 180 mg loading dose and 90 mg twice daily maintenance dose
Other Names:
  • Brilique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite primary outcome measure consisting of Death / Re-infarction / Stroke / Serious bleeding requiring transfusion or prolonged hospitalization / Urgent Target Vessel Revascularization.
Time Frame: Within 7 days after Randomization.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite secondary outcome measure consisting of Cadiovascular death / Non-fatal myocardial infarction / Stroke.
Time Frame: Within 30 days and one year after Randomization.

Definition:

Cardiovascular death defined as a death with a demonstrable cardiovascular cause, or any death that is not clearly attributable to a non-cardiovascular cause.

Non-fatal myocardial infarction must be distinct from the index event and is defined according to the Third Universal Definition of Myocardial Infarction.

Units: The percentage of randomized patients is the total number of randomized patients experiencing Cadiovascular death / Non-fatal myocardial infarction / Stroke divided by number of randomized patients in the treatment arm multiplied by 100.
Within 30 days and one year after Randomization.
Stent thrombosis.
Time Frame: Within 30 days and one year after Randomization.
Definition: Academic Research Consortium (ARC) criteria were used to define ST. Units: The percentage of randomized patients is the total number of randomized patients experiencing Stent thrombosis divided by number of randomized patients in the treatment arm multiplied by 100.
Within 30 days and one year after Randomization.
Occurence of bleeding according to the TIMI and BARC criteria.
Time Frame: Within 30 days and one year after Randomization.
TIMI criteria - Thrombolysis In Myocardial Infarction Criteria BARC criteria - Bleeding Academic Research Consortium criteria Units: The percentage of randomized patients is the total number of randomized patients experiencing bleeding according to the TIMI and BARC criteria divided by number of randomized patients in the treatment arm multiplied by 100.
Within 30 days and one year after Randomization.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome measure consisting of Cadiovascular death / Non-fatal myocardial infarction / Stroke in patients with Killip III/IV.
Time Frame: Within 7 days after Randomization.
The percentage of randomized patients is the total number of randomized patients with Killip class III or IV experiencing Cardiovascular death / Non-fatal myocardial infarction / Stroke divided by number of randomized patients with Killip class III or IV in the treatment arm multiplied by 100.
Within 7 days after Randomization.

Collaborators and Investigators

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

Sponsor

Faculty Hospital Kralovske Vinohrady

Investigators

  • Principal Investigator: 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

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 (Actual)

January 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

June 12, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-VP/04/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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