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This study evaluates the efficacy of Prasugrel and Ticagrelor in the treatment of acute myocardial infarction.
Study objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with Prasugrel | 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. |
|
| Patients treated with ticagrelor | Experimental | Ticagrelor Loading dose: 180 mg Maintenance dose: 90mg twice-daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel | Drug | Prasugrel 60 mg loading dose and 10mg/5mg once daily maintenance dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zuzana Motovska, MD PhD | University Hospital Kralovske Vinohrady, Prague, Czech Republic | Principal Investigator |
| Petr Widimsky, Prof MD DrSc | University Hospital Kralovske Vinohrady, Prague, Czech Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty Hospital Kralovske Vinohrady | Prague | 10034 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27576777 | Background | 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. | |
| 29154813 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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| Ticagrelor | Drug | Ticagrelor 180 mg loading dose and 90 mg twice daily maintenance dose |
|
|
| Within 30 days and one year after Randomization. |
| 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. |
| 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. |
| Within 7 days after Randomization. |
| Derived |
| 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. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |