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

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

ticagrelor

clopidogrel

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Inhibition of Platelet Reactivity, ticagrelor, clopidogrel, Pharmacodynamics, Pharmacokinetics

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Low dose ticagrelor

standard dose ticagrelor

standard dose clopidogrel

Arm Description

60mg bid

90mg bid

75mg qd

Outcomes

Primary Outcome Measures

P2Y12 reaction units(PRU)

P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay

Secondary Outcome Measures

Percentage inhibition of platelet aggregation

Aggregation units(AU), Area Under the Curve(AUC)

by Multiplate analyzer

Percentage of low-responsive patients

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

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)

Death, Myocardial Infarction, stent thrombosis, stroke,

Adverse event

including bleeding by TIMI/PLATO criteria, dyspnea, bradycardia, syncope,

Drug tolerance

Drug tolerance is evaluated as adverse event following discontinuation of drug administration

Full Information

NCT ID

NCT02319941

First Posted

December 15, 2014

Last Updated

June 15, 2017

Sponsor

Seung-Jung Park

Collaborators

AstraZeneca, Roche Pharma AG, KBM pharm

1. Study Identification

Unique Protocol Identification Number

NCT02319941

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

May 20, 2015 (Actual)

Primary Completion Date

February 14, 2017 (Actual)

Study Completion Date

March 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Seung-Jung Park

Collaborators

AstraZeneca, Roche Pharma AG, KBM pharm

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

Inhibition of Platelet Reactivity, ticagrelor, clopidogrel, Pharmacodynamics, Pharmacokinetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low dose ticagrelor

Arm Type

Experimental

Arm Description

60mg bid

Arm Title

standard dose ticagrelor

Arm Type

Active Comparator

Arm Description

90mg bid

Arm Title

standard dose clopidogrel

Arm Type

Active Comparator

Arm Description

75mg qd

Intervention Type

Drug

Intervention Name(s)

ticagrelor

Intervention Type

Drug

Intervention Name(s)

clopidogrel

Primary Outcome Measure Information:

Title

P2Y12 reaction units(PRU)

Description

P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay

Time Frame

8 hours and 30days after first randomized dose

Secondary Outcome Measure Information:

Title

Percentage inhibition of platelet aggregation

Time Frame

0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment

Title

Aggregation units(AU), Area Under the Curve(AUC)

Description

by Multiplate analyzer

Time Frame

0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment

Title

Percentage of low-responsive patients

Description

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, 8,24 hours and 30 days after first randomized study treatment

Title

Description of the pharmacokinetic (PK) profile for Ticagrelor and its metabolite AR-C124910XX

Description

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

0, 0.5, 1, 2, 4, 8, 10,24 hours after first randomized study treatment

Title

MACE(Major adverse cardiac event)

Description

Death, Myocardial Infarction, stent thrombosis, stroke,

Time Frame

30 days after first randomized study treatment

Title

Adverse event

Description

including bleeding by TIMI/PLATO criteria, dyspnea, bradycardia, syncope,

Time Frame

30 days after first randomized study treatment

Title

Drug tolerance

Description

Drug tolerance is evaluated as adverse event following discontinuation of drug administration

Time Frame

30 days after first randomized study treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

State/Province

Songpa-gu

ZIP/Postal Code

138-736

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

29622168

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.

Results Reference

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

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