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This is a single-center, randomized, single-blind, investigator-initiated, pharmacodynamic study with a parallel design. Patients with ST elevation myocardial infarction, undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1 ratio to the following treatment groups:
Group Α: Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD)starting 12±6 hours post LD, until Day 5 (5 days after randomization) Group Β: Prasugrel 60 mg LD followed by 10mg x1 MD starting 24 hours post LD, until Day 5 (5 days after randomization).
Platelet reactivity assessment will be performed at randomization (Hour 0) and at 1, 2, 6, 24 hours after randomization, and on Day 5. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and serious adverse events (bleeding, other adverse events)will be performed until Day 5.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel | Active Comparator | Prasugrel 60mg LD followed by 10mg MD starting post 24 hours |
|
| Ticagrelor | Experimental | Ticagrelor 180mg LD followed by 90mg x2 MD starting post 12±6 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel | Drug | Prasugrel 60mg LD followed by 10mg x1 MD starting post 24 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet reactivity | Platelet reactivity Platelet assessed by VerifyNow P2Y12 assay 1 hour post randomization | 1hour |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet reactivity | Platelet Reactivity assessed by Multiplate analyzer assay 1 hour post randomization | 1 hour |
| Platelet reactivity | Platelet reactivity assessed by the VerifyNow assay 2 hours post randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Department Patras University Hospital | Rio | Achaia | 26500 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23169985 | Derived | Alexopoulos D, Xanthopoulou I, Gkizas V, Kassimis G, Theodoropoulos KC, Makris G, Koutsogiannis N, Damelou A, Tsigkas G, Davlouros P, Hahalis G. Randomized assessment of ticagrelor versus prasugrel antiplatelet effects in patients with ST-segment-elevation myocardial infarction. Circ Cardiovasc Interv. 2012 Dec;5(6):797-804. doi: 10.1161/CIRCINTERVENTIONS.112.972323. Epub 2012 Nov 20. |
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| Ticagrelor |
| Drug |
Ticagrelor 180mg LD followed by 90mg x2 MD starting after 12±6 hours |
|
| 2 hours |
| Platelet reactivity | Platelet Reactivity assessed by Multiplate analyzer 2 hours post randomization | 2 hours |
| Platelet reactivity | Platelet Reactivity assessed by VerifyNow P2Y12 assay 6 hours post randomization | 6 hours |
| Platelet reactivity | Platelet Reactivity assessed by Multiplate analyzer 6 hours post randomization | 6 hours |
| Platelet reactivity | Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization | 24 hours |
| Platelet reactivity | Platelet Reactivity assessed by Multiplate analyzer 24 hours post randomization | 24 hours |
| Platelet reactivity | Platelet Reactivity assessed by VerifyNow P2Y12 assay 5 days post randomization | 5 days |
| Platelet reactivity | Platelet Reactivity assessed by Multiplate analyzer 5 days post randomization | 5 days |
| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| 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 |
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