Clinical trial NCT02319941: Comparison of Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients With Acute Coronary Syndromes
Official title: Comparison of Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients With Acute Coronary Syndromes; Pharmacodynamics and Pharmacokinetics Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Keywords: Inhibition of Platelet Reactivity
ticagrelor
clopidogrel
Pharmacodynamics
Pharmacokinetics
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Roche Pharma AG
name: KBM pharm
First posted: 2014-12-18
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: P2Y12 reaction units(PRU)
timeFrame: 8 hours and 30days after first randomized dose
Secondary outcomes:
measure: Percentage inhibition of platelet aggregation
timeFrame: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
measure: Aggregation units(AU), Area Under the Curve(AUC)
timeFrame: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
measure: Percentage of low-responsive patients
timeFrame: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
measure: Description of the pharmacokinetic (PK) profile for Ticagrelor and its metabolite AR-C124910XX
timeFrame: 0, 0.5, 1, 2, 4, 8, 10,24 hours after first randomized study treatment
measure: MACE(Major adverse cardiac event)
timeFrame: 30 days after first randomized study treatment
measure: Adverse event
timeFrame: 30 days after first randomized study treatment
measure: Drug tolerance
timeFrame: 30 days after first randomized study treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
References:
citation: Park DW, Lee PH, Jang S, Lim HS, Kang DY, Lee CH, Ahn JM, Yun SC, Park SW, Park SJ. Effect of Low-Dose Versus Standard-Dose Ticagrelor and Clopidogrel on Platelet Inhibition in Acute Coronary Syndromes. J Am Coll Cardiol. 2018 Apr 10;71(14):1594-1595. doi: 10.1016/j.jacc.2018.02.010. No abstract available.