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Completed

NCT Number: NCT02808767

Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction

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

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Key information

Conditions

Myocardial Infarction Angioplasty, Balloon, Coronary Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Platelet Aggregation Inhibitors Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty Hospital Kralovske Vinohrady

Prague, 10034, Czechia

About this study

Study objectives:

  • Compare the efficacy and safety of prasugrel and ticagrelor in acute myocardial infarction treated with emergent PCI.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Prasugrel

Drug

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

Other names: Efient

Ticagrelor

Drug

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

Other names: Brilique

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Faculty Hospital Kralovske Vinohrady

Other Gov

Registry information

Acronym: PRAGUE-18

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jun 22, 2016
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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