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OpenTrials
Completed

NCT Number: NCT02319941

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

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

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor

Drug

clopidogrel

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • AstraZeneca
  • KBM pharm
  • Roche Pharma AG

Registry information

Official study 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

Acronym: OPTIMA

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 18, 2014
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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