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

Myocardial Infarction Clinical Trial

— PRAGUE-18  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808767
• Other study ID #: EK-VP/04/2013
• Status: Completed
• Phase: Phase 4
• First received: June 12, 2016
• Last updated: August 10, 2017
• Start date: January 2013
• Est. completion date: May 2017

Study information

• Verified date: August 2017
• Source: Faculty Hospital Kralovske Vinohrady
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1226
• Est. completion date: May 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angioplasty, Balloon, Coronary
• Infarction
• Myocardial Infarction
• Platelet Aggregation Inhibitors

Intervention

Drug:
• Prasugrel
Prasugrel 60 mg loading dose and 10mg/5mg once daily maintenance dose
• Ticagrelor
Ticagrelor 180 mg loading dose and 90 mg twice daily maintenance dose

Locations

Country	Name	City	State
Czechia	Faculty Hospital Kralovske Vinohrady	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Faculty Hospital Kralovske Vinohrady

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

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. Epub 2016 Aug 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite outcome measure consisting of Cadiovascular death / Non-fatal myocardial infarction / Stroke in patients with Killip III/IV.	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.	Within 7 days after Randomization.
Primary	Composite primary outcome measure consisting of Death / Re-infarction / Stroke / Serious bleeding requiring transfusion or prolonged hospitalization / Urgent Target Vessel Revascularization.	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	Within 7 days after Randomization.
Secondary	Composite secondary outcome measure consisting of Cadiovascular death / Non-fatal myocardial infarction / Stroke.	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.	Within 30 days and one year after Randomization.
Secondary	Stent thrombosis.	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.	Within 30 days and one year after Randomization.
Secondary	Occurence of bleeding according to the TIMI and BARC criteria.	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.	Within 30 days and one year after Randomization.