Clinical trial NCT02808767: Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction
Official title: Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Angioplasty, Balloon, Coronary
Platelet Aggregation Inhibitors
Keywords: Acute myocardial infarction
Primary coronary intervention
Antiplatelet therapy
Lead sponsor: Faculty Hospital Kralovske Vinohrady
Sponsor class: OTHER_GOV
First posted: 2016-06-22
Enrollment: 1226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Composite primary outcome measure consisting of Death / Re-infarction / Stroke / Serious bleeding requiring transfusion or prolonged hospitalization / Urgent Target Vessel Revascularization.
timeFrame: Within 7 days after Randomization.
Secondary outcomes:
measure: Composite secondary outcome measure consisting of Cadiovascular death / Non-fatal myocardial infarction / Stroke.
timeFrame: Within 30 days and one year after Randomization.
measure: Stent thrombosis.
timeFrame: Within 30 days and one year after Randomization.
measure: Occurence of bleeding according to the TIMI and BARC criteria.
timeFrame: Within 30 days and one year after Randomization.
Other outcomes:
measure: Composite outcome measure consisting of Cadiovascular death / Non-fatal myocardial infarction / Stroke in patients with Killip III/IV.
timeFrame: Within 7 days after Randomization.
Locations:
city: Prague
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady
Study officials:
affiliation: University Hospital Kralovske Vinohrady, Prague, Czech Republic
name: Zuzana Motovska, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Kralovske Vinohrady, Prague, Czech Republic
name: Petr Widimsky, Prof MD DrSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.