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

Sponsor

Faculty Hospital Kralovske Vinohrady (Other)

Overall Status

Completed

CT.gov ID

NCT02808767

Collaborator

(none)

1,226

Enrollment

Location

Arms

51.9

Actual Duration (Months)

23.6

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Study Design

Study Type:

Interventional

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 :

Jan 1, 2013

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty Hospital Kralovske Vinohrady	Prague		Czechia	10034

Sponsors and Collaborators

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