Comparison of Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients With Acute Coronary Syndromes
- Registration Number
- NCT02319941
- Lead Sponsor
- Seung-Jung Park
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- ST elevation or non ST elevation acute coronary syndrome patients of chest pain within 24 hours
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard dose ticagrelor ticagrelor 90mg bid Low dose ticagrelor ticagrelor 60mg bid standard dose clopidogrel clopidogrel 75mg qd
- Primary Outcome Measures
Name Time Method P2Y12 reaction units(PRU) 8 hours and 30days after first randomized dose P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay
- Secondary Outcome Measures
Name Time Method 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
MACE(Major adverse cardiac event) 30 days after first randomized study treatment Death, Myocardial Infarction, stent thrombosis, stroke,
Adverse event 30 days after first randomized study treatment including bleeding by TIMI/PLATO criteria, dyspnea, bradycardia, syncope,
Percentage inhibition of platelet aggregation 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment Drug tolerance 30 days after first randomized study treatment Drug tolerance is evaluated as adverse event following discontinuation of drug administration
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Songpa-gu, Korea, Republic of