Cardiology Department Patras University Hospital
Rio, Achaia, 26500, Greece
NCT Number: NCT01463163
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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Notify Me18 year–95 year
All sexes
Interventional
Phase 4
Rio, Achaia, 26500, Greece
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prasugrel 60mg LD followed by 10mg x1 MD starting post 24 hours
Ticagrelor 180mg LD followed by 90mg x2 MD starting after 12±6 hours
Time frame: 1hour
Platelet reactivity Platelet assessed by VerifyNow P2Y12 assay 1 hour post randomization
Time frame: 1 hour
Platelet Reactivity assessed by Multiplate analyzer assay 1 hour post randomization
Time frame: 2 hours
Platelet reactivity assessed by the VerifyNow assay 2 hours post randomization
Time frame: 2 hours
Platelet Reactivity assessed by Multiplate analyzer 2 hours post randomization
Time frame: 6 hours
Platelet Reactivity assessed by VerifyNow P2Y12 assay 6 hours post randomization
Time frame: 6 hours
Platelet Reactivity assessed by Multiplate analyzer 6 hours post randomization
Time frame: 24 hours
Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization
Time frame: 24 hours
Platelet Reactivity assessed by Multiplate analyzer 24 hours post randomization
Time frame: 5 days
Platelet Reactivity assessed by VerifyNow P2Y12 assay 5 days post randomization
Time frame: 5 days
Platelet Reactivity assessed by Multiplate analyzer 5 days post randomization
University of Patras
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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