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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Myocardial Infarction Angioplasty, Balloon, Coronary Platelet Aggregation Inhibitors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Prasugrel

Intervention Type DRUG

Prasugrel 60 mg loading dose and 10mg/5mg once daily maintenance dose

Patients treated with ticagrelor

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

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

Ticagrelor 180 mg loading dose and 90 mg twice daily maintenance dose

Interventions

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Prasugrel

Prasugrel 60 mg loading dose and 10mg/5mg once daily maintenance dose

Intervention Type DRUG

Ticagrelor

Ticagrelor 180 mg loading dose and 90 mg twice daily maintenance dose

Intervention Type DRUG

Other Intervention Names

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Efient Brilique

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No