Overview

This trial is active, not recruiting.

Conditions myocardial infarction, angioplasty, balloon, coronary, platelet aggregation inhibitors
Treatments prasugrel, ticagrelor
Phase phase 4
Sponsor Faculty Hospital Kralovske Vinohrady
Start date January 2013
End date May 2016
Trial size 1226 participants
Trial identifier NCT02808767, EK-VP/04/2013

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
prasugrel Efient
Prasugrel 60 mg loading dose and 10mg/5mg once daily maintenance dose
(Experimental)
Ticagrelor Loading dose: 180 mg Maintenance dose: 90mg twice-daily
ticagrelor Brilique
Ticagrelor 180 mg loading dose and 90 mg twice daily maintenance dose

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
Composite secondary outcome measure consisting of Cadiovascular death / Non-fatal myocardial infarction / Stroke.
time frame: Within 30 days and one year after Randomization.
Stent thrombosis.
time frame: Within 30 days and one year after Randomization.
Occurence of bleeding according to the TIMI and BARC criteria.
time frame: Within 30 days and one year after Randomization.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction
Principal investigator Zuzana Motovska, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Faculty Hospital Kralovske Vinohrady.