Comparison of Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients With Acute Coronary Syndromes

Acute Coronary Syndrome Clinical Trial

— OPTIMA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319941
• Other study ID #: AMCCV2014-07
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2014
• Last updated: June 15, 2017
• Start date: May 20, 2015
• Est. completion date: March 10, 2017

Study information

• Verified date: June 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 10, 2017
• Est. primary completion date: February 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• ticagrelor

• clopidogrel

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (4)

Lead Sponsor	Collaborator
Seung-Jung Park	AstraZeneca, KBM pharm, Roche Pharma AG

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P2Y12 reaction units(PRU)	P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay	8 hours and 30days after first randomized dose
Secondary	Percentage inhibition of platelet aggregation		0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
Secondary	Aggregation units(AU), Area Under the Curve(AUC)	by Multiplate analyzer	0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
Secondary	Percentage of low-responsive patients	Low-responsive patients is defined as PRU = 235 from VerifyNow P2Y12 and/or percentage of platelet inhibition <15%	0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
Secondary	Description of the pharmacokinetic (PK) profile for Ticagrelor and its metabolite AR-C124910XX	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	0, 0.5, 1, 2, 4, 8, 10,24 hours after first randomized study treatment
Secondary	MACE(Major adverse cardiac event)	Death, Myocardial Infarction, stent thrombosis, stroke,	30 days after first randomized study treatment
Secondary	Adverse event	including bleeding by TIMI/PLATO criteria, dyspnea, bradycardia, syncope,	30 days after first randomized study treatment
Secondary	Drug tolerance	Drug tolerance is evaluated as adverse event following discontinuation of drug administration	30 days after first randomized study treatment