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

Primary Purpose

Myocardial Infarction, Angioplasty, Balloon, Coronary, Platelet Aggregation Inhibitors

Status
Completed
Phase
Phase 4
Locations
Czechia
Study Type
Interventional
Intervention
Prasugrel
Ticagrelor
Sponsored by
Faculty Hospital Kralovske Vinohrady
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Acute myocardial infarction, Primary coronary intervention, Antiplatelet therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty Hospital Kralovske Vinohrady

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients treated with Prasugrel

Patients treated with ticagrelor

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Composite secondary outcome measure consisting of Cadiovascular death / Non-fatal myocardial infarction / Stroke.
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.
Stent thrombosis.
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.
Occurence of bleeding according to the TIMI and BARC criteria.
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.

Full Information

First Posted
June 12, 2016
Last Updated
August 10, 2017
Sponsor
Faculty Hospital Kralovske Vinohrady
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1. Study Identification

Unique Protocol Identification Number
NCT02808767
Brief Title
Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction
Acronym
PRAGUE-18
Official Title
Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty Hospital Kralovske Vinohrady

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Angioplasty, Balloon, Coronary, Platelet Aggregation Inhibitors
Keywords
Acute myocardial infarction, Primary coronary intervention, Antiplatelet therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients treated with Prasugrel
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients treated with ticagrelor
Arm Type
Experimental
Arm Description
Ticagrelor Loading dose: 180 mg Maintenance dose: 90mg twice-daily
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Other Intervention Name(s)
Efient
Intervention Description
Prasugrel 60 mg loading dose and 10mg/5mg once daily maintenance dose
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brilique
Intervention Description
Ticagrelor 180 mg loading dose and 90 mg twice daily maintenance dose
Primary Outcome Measure Information:
Title
Composite primary outcome measure consisting of Death / Re-infarction / Stroke / Serious bleeding requiring transfusion or prolonged hospitalization / Urgent Target Vessel Revascularization.
Description
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
Time Frame
Within 7 days after Randomization.
Secondary Outcome Measure Information:
Title
Composite secondary outcome measure consisting of Cadiovascular death / Non-fatal myocardial infarction / Stroke.
Description
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.
Time Frame
Within 30 days and one year after Randomization.
Title
Stent thrombosis.
Description
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.
Time Frame
Within 30 days and one year after Randomization.
Title
Occurence of bleeding according to the TIMI and BARC criteria.
Description
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.
Time Frame
Within 30 days and one year after Randomization.
Other Pre-specified Outcome Measures:
Title
Composite outcome measure consisting of Cadiovascular death / Non-fatal myocardial infarction / Stroke in patients with Killip III/IV.
Description
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.
Time Frame
Within 7 days after Randomization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zuzana Motovska, MD PhD
Organizational Affiliation
University Hospital Kralovske Vinohrady, Prague, Czech Republic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Petr Widimsky, Prof MD DrSc
Organizational Affiliation
University Hospital Kralovske Vinohrady, Prague, Czech Republic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty Hospital Kralovske Vinohrady
City
Prague
ZIP/Postal Code
10034
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27576777
Citation
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.
Results Reference
background
PubMed Identifier
29154813
Citation
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.
Results Reference
derived

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

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