Acute Coronary Syndrome
Conditions
Keywords
Inhibition of Platelet Reactivity, ticagrelor, clopidogrel, Pharmacodynamics, Pharmacokinetics
Brief summary
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
Interventions
DRUGticagrelor
DRUGclopidogrel
Sponsors
AstraZeneca
Roche Pharma AG
KBM pharm
Seung-Jung Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ST elevation or non ST elevation acute coronary syndrome patients of chest pain within 24 hours
Exclusion criteria
* Known hypersensitivity to clopidogrel and ticagrelor and aspirin * Treatment with anticoagulants * Exposure to a thrombolytic agent within 24 hours prior to randomization * Use of glycoprotein IIb - IIIa inhibitors at randomization * History of major hemorrhage (intracranial, gastrointestinal, etc.) * clotting disorder and/or bleeding disorder * Any history of Severe renal or hepatic dysfunction * Hematologic disorder including a Hemoglobin less than 10 g/L or a platelet count less than 80,000 cells/mm3 * Cardiac shock, severe left ventricular dysfunction LVEF less than 30% * Sick sinus syndrome or second degree of av block without permanent pacemaker * No concurrent cytochrome p450 3a inhibitors and enhancers within 2 weeks * Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg,drug and alcohol abuse, mental illness) or that could prevent, limit, or confound the protocol-specified assessments. * Life expectancy of less than 6 months * Pregnancy or lactating * Participation in any drug study in the previous 3 months * Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| P2Y12 reaction units(PRU) | 8 hours and 30days after first randomized dose | P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aggregation units(AU), Area Under the Curve(AUC) | 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment | by Multiplate analyzer |
| Percentage of low-responsive patients | 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% |
| Description of the pharmacokinetic (PK) profile for Ticagrelor and its metabolite AR-C124910XX | 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 |
| Percentage inhibition of platelet aggregation | 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment | — |
| Adverse event | 30 days after first randomized study treatment | including bleeding by TIMI/PLATO criteria, dyspnea, bradycardia, syncope, |
| Drug tolerance | 30 days after first randomized study treatment | Drug tolerance is evaluated as adverse event following discontinuation of drug administration |
| MACE(Major adverse cardiac event) | 30 days after first randomized study treatment | Death, Myocardial Infarction, stent thrombosis, stroke, |
Countries
South Korea
Outcome results
None listed