Comparison of Antiplatelet Effect of Ticagrelor vs Tirofiban in Patients With Non-ST Elevation Acute Coronary Syndrome (TE-CLOT)

December 16, 2012 updated by: June Hong Kim, Pusan National University Yangsan Hospital

Ticagrelor vs. Tirofiban, Comparison of Anti-platelet Effects in Patients With Non-ST Elevation Acute Coronary Syndrome(TE-CLOT Trial : Ticagrelor's Effect for CLOT Prevention) ; A Single Center, Open-label Randomized Controlled Study

This is a single-center, open-label prospective randomized pharmacodynamic investigation of two anti platelet regimens in patients who are planned to undergo PCI for non-ST segment elevation acute coronary syndrome(NSTE-ACS) for 24 hours

  1. Ticagrelor : loading dose(180mg) followed by maintenance dose(90mg bid)

  2. Tirofiban : 0.4ug/kg/min for 30min followed by 0.1ug/kg/min

    • both agents will be given on top of aspirin

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In combination with aspirin, P2Y12 receptor antagonist or glycoprotein IIb/IIIa inhibitor(GPI) is now a recommended drug as the standard dual antiplatelet regimen in patients with acute coronary syndrome(1).

Ticagrelor is a newly developed oral P2Y12 receptor inhibitor. It shows faster, greater and more consistent platelet inhibition as compared with previous P2Y12 receptor antagonist clopidogrel(2) and it also shows better clinical outcome and similar risk for bleeding as compared with clopidogrel(3).Interestingly, pharmacodynamic data of some studies showed excellent effect of ticagrelor in terms of inhibiting platelet activation apparently as high as that of GPI(2,4).

Primary hypothesis: Ticagrelor have a comparable efficacy in platelet inhibition to GPI in patients with non-ST segment elevation acute coronary syndrome.

Statistical design : non-inferiority test

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Kyeongsangnamdo
      • Yangsan, Kyeongsangnamdo, Korea, Republic of, 626-770
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • June Hong Kim, MD,PhD
        • Sub-Investigator:
          • Dongcheul Han, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with recent or current ischemic symptoms at the time of randomization will be eligible if 2 of the following criteria are met: ST-T change indicating ischemia; a positive test of biomarker indication myocardial necrosis; or one of several risk factors(age ≥60 years
  • Previous myocardial infarction or coronary artery bypass grafting [CABG]
  • Coronary artery disease with stenosis of ≥50% in at least two vessels
  • Previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization
  • Diabetes mellitus
  • Peripheral arterial disease; or chronic renal dysfunction, defined as a creatinine clearance of <60 ml per minute per 1.73 m2 of body surface area)

Exclusion Criteria:

  1. Administration of fibrinolytic or any GP IIb/IIIa inhibitors for the treatment of current AMI
  2. Major surgery or trauma within 30 days
  3. Active bleeding
  4. Previous stroke in the last six months
  5. Oral anticoagulant therapy
  6. Pre-existing thrombocytopenia
  7. Vasculitis
  8. Hypertensive retinopathy
  9. Severe hepatic failure
  10. Severe renal failure requiring hemodialysis
  11. Documented allergy/intolerance or contraindication to tirofiban or P2Y12 inhibitor
  12. Uncontrolled hypertension (systolic or diastolic arterial pressure >180 mmHg or 120, respectively, despite medical therapy)
  13. Limited life expectancy, e.g. neoplasms, others
  14. Inability to obtain informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ticagrelor
loading dose(180mg) followed by maintenance dose(90mg bid)
Drug: Ticagrelor
loading dose(180mg) followed by maintenance dose(90mg bid)
Active Comparator: Tirofiban
0.4ug/kg/min for 30min followed by 0.1ug/kg/min
Drug: Tirofiban
0.4ug/kg/min for 30min followed by 0.1ug/kg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage IPA after 20µmol/l ADP at 2 hour
Time Frame: 2 hours
Blood samples anticoagulated with 0.129 mol/l sodium citrate will be collected for platelet reactivity. Platelet-rich plasma, obtained by centrifuging whole blood for 15 min at 100 g, will be stimulated with 20 µmol/l ADP and aggregation will be assessed using a light transmittance aggregometer(Chronolog, USA).
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage IPA at 8 hours after 20µMol ADP, TRAP, Arachidonic acid, Collagen
Time Frame: 8 hours
Blood samples anticoagulated with 0.129 mol/l sodium citrate will be collected for platelet reactivity. Platelet-rich plasma, obtained by centrifuging whole blood for 15 min at 100 g, will be stimulated with 20 µmol/l ADP, TRAP, arachidonic acid and collagen and aggregation will be assessed using a light transmittance aggregometer(Chrono-log, USA).
8 hours
Percentage IPA at 8 hours after 20µMol ADP, TRAP, Arachidonic acid, Collagen
Time Frame: 24 hours
Blood samples with 0.129 mol/l sodium citrate will be collected for platelet reactivity. Platelet-rich plasma, obtained by centrifuging whole blood for 15 min at 100 g, will be stimulated with 20 µmol/l ADP, TRAP, arachidonic acid and collagen and aggregation will be assessed using a light transmittance aggregometer(Chrono-log, USA).
24 hours
periprocedural bleeding
Time Frame: 0~24 hours
Periprocedural bleeding will be monitored and described according to BARC and TIMI definition
0~24 hours
Peak cardiac enzyme level
Time Frame: 0~24 hours
From blood samples at 0, 2H, 8H and 24H, CK-MB and Troponin I will be measured
0~24 hours
Percentage IPA after TRAP, arachidonic acid, collagen at 2 hours
Time Frame: 2 hours
Blood samples anticoagulated with 0.129 mol/l sodium citrate will be collected for platelet reactivity. Platelet-rich plasma, obtained by centrifuging whole blood for 15 min at 100 g, will be stimulated with TRAP, arachidonic acid and collagen and aggregation will be assessed using a light transmittance aggregometer(Chrono-log, USA).
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Yangsan Hospital

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: June Hong Kim, MD,PhD, Pusan National University Yangsan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

August 5, 2012

First Submitted That Met QC Criteria

August 7, 2012

First Posted (Estimate)

August 8, 2012

Study Record Updates

Last Update Posted (Estimate)

December 18, 2012

Last Update Submitted That Met QC Criteria

December 16, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISSBRIL0080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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