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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02319941
Recruitment Status : Completed
First Posted : December 18, 2014
Last Update Posted : June 16, 2017
Sponsor:
Collaborators:
AstraZeneca
Roche Pharma AG
KBM pharm
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

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

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: ticagrelor Drug: clopidogrel Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 20, 2015
Actual Primary Completion Date : February 14, 2017
Actual Study Completion Date : March 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low dose ticagrelor
60mg bid
Drug: ticagrelor
Active Comparator: standard dose ticagrelor
90mg bid
Drug: ticagrelor
Active Comparator: standard dose clopidogrel
75mg qd
Drug: clopidogrel



Primary Outcome Measures :
  1. P2Y12 reaction units(PRU) [ Time Frame: 8 hours and 30days after first randomized dose ]
    P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay


Secondary Outcome Measures :
  1. Percentage inhibition of platelet aggregation [ Time Frame: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment ]
  2. Aggregation units(AU), Area Under the Curve(AUC) [ Time Frame: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment ]
    by Multiplate analyzer

  3. Percentage of low-responsive patients [ Time Frame: 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%

  4. Description of the pharmacokinetic (PK) profile for Ticagrelor and its metabolite AR-C124910XX [ Time Frame: 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

  5. MACE(Major adverse cardiac event) [ Time Frame: 30 days after first randomized study treatment ]
    Death, Myocardial Infarction, stent thrombosis, stroke,

  6. Adverse event [ Time Frame: 30 days after first randomized study treatment ]
    including bleeding by TIMI/PLATO criteria, dyspnea, bradycardia, syncope,

  7. Drug tolerance [ Time Frame: 30 days after first randomized study treatment ]
    Drug tolerance is evaluated as adverse event following discontinuation of drug administration



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319941


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Songpa-gu, Korea, Republic of, 138-736
Sponsors and Collaborators
Seung-Jung Park
AstraZeneca
Roche Pharma AG
KBM pharm
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seung-Jung Park, MD, PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02319941    
Other Study ID Numbers: AMCCV2014-07
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Keywords provided by Seung-Jung Park, Asan Medical Center:
Inhibition of Platelet Reactivity
ticagrelor
clopidogrel
Pharmacodynamics
Pharmacokinetics
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs