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

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ClinicalTrials.gov Identifier: NCT02808767
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Zuzana Motovska, Faculty Hospital Kralovske Vinohrady

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

Condition or disease Intervention/treatment Phase
Myocardial Infarction Angioplasty, Balloon, Coronary Platelet Aggregation Inhibitors Drug: Prasugrel Drug: Ticagrelor Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction
Actual Study Start Date : January 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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 Name: 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 Name: Brilique




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02808767


Locations
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Czechia
Faculty Hospital Kralovske Vinohrady
Prague, Czechia, 10034
Sponsors and Collaborators
Faculty Hospital Kralovske Vinohrady
Investigators
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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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zuzana Motovska, Accociate Professor, Faculty Hospital Kralovske Vinohrady
ClinicalTrials.gov Identifier: NCT02808767     History of Changes
Other Study ID Numbers: EK-VP/04/2013
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zuzana Motovska, Faculty Hospital Kralovske Vinohrady:
Acute myocardial infarction
Primary coronary intervention
Antiplatelet therapy
Additional relevant MeSH terms:
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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