Suspended

TE-CLOTTicagrelor 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

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What is being tested

Ticagrelor

+ Tirofiban

Drug
Who is being recruted

Cardiovascular Diseases+2

+ Heart Diseases

+ Vascular Diseases

From 18 to 80 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorPusan National University Yangsan Hospital
Study ContactJune Hong Kim, MD,PhDMore contacts
Last updated: December 18, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01660373
Principal SponsorPusan National University Yangsan Hospital
Study ContactJune Hong Kim, MD,PhDMore contacts
Last updated: December 18, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

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

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesVascular DiseasesMyocardial IschemiaAcute Coronary Syndrome

Criteria

6 inclusion criteria required to participate
Coronary artery disease with stenosis of >= 50% in at least two vessels
Diabetes mellitus
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
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)
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14 exclusion criteria prevent from participating
Active bleeding
Administration of fibrinolytic or any GP IIb/IIIa inhibitors for the treatment of current AMI
Documented allergy/intolerance or contraindication to tirofiban or P2Y12 inhibitor
Hypertensive retinopathy
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
loading dose(180mg) followed by maintenance dose(90mg bid)

Group II

Active Comparator
0.4ug/kg/min for 30min followed by 0.1ug/kg/min

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Pusan National University Yangsan Hospital

Yangsan, South KoreaOpen Pusan National University Yangsan Hospital in Google Maps
SuspendedOne Study Center