Asan Medical Center
Seoul, Songpa-gu, 138-736, South Korea
NCT Number: NCT02319941
The purpose of this study is to compare Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients with Acute Coronary Syndromes
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Notify Me20 year–80 year
All sexes
Interventional
Phase 2
Seoul, Songpa-gu, 138-736, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 8 hours and 30days after first randomized dose
P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay
Time frame: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
Time frame: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
by Multiplate analyzer
Time frame: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
Low-responsive patients is defined as PRU ≥ 235 from VerifyNow P2Y12 and/or percentage of platelet inhibition <15%
Time frame: 0, 0.5, 1, 2, 4, 8, 10,24 hours after first randomized study treatment
in terms of maximum concentration (Cmax),time to maximum concentration (tmax) and area under the concentration curve from time zero to infinity (AUC), t1/2, CL/F
Time frame: 30 days after first randomized study treatment
Death, Myocardial Infarction, stent thrombosis, stroke,
Time frame: 30 days after first randomized study treatment
including bleeding by TIMI/PLATO criteria, dyspnea, bradycardia, syncope,
Time frame: 30 days after first randomized study treatment
Drug tolerance is evaluated as adverse event following discontinuation of drug administration
Seung-Jung Park
Other
Comparison of Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients With Acute Coronary Syndromes; Pharmacodynamics and Pharmacokinetics Study
Acronym: OPTIMA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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