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

Faculty Hospital Kralovske Vinohrady

Status and phase: Completed; Phase 4

Conditions: Angioplasty, Balloon, Coronary; Platelet Aggregation Inhibitors; Myocardial Infarction

Treatments: Drug: Prasugrel; Drug: Ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT02808767

EK-VP/04/2013

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,226 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,226 participants in 2 patient groups

Patients treated with Prasugrel

Experimental group

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.

Treatment:

Drug: Prasugrel

Patients treated with ticagrelor

Experimental group

Description:

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

Treatment:

Drug: Ticagrelor