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

Sponsor

Pusan National University Yangsan Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01660373

Collaborator

AstraZeneca (Industry)

100

Enrollment

Location

Arms

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Ticagrelor : loading dose(180mg) followed by maintenance dose(90mg bid)
Tirofiban : 0.4ug/kg/min for 30min followed by 0.1ug/kg/min

both agents will be given on top of aspirin

Condition or Disease	Intervention/Treatment	Phase
Non-ST Segment Elevation Acute Coronary Syndrome	Drug: Tirofiban Drug: Ticagrelor	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2012

Anticipated Primary Completion Date :

Aug 1, 2013

Anticipated Study Completion Date :

Aug 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Percentage IPA after 20µmol/l ADP at 2 hour [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).

Secondary Outcome Measures

Percentage IPA at 8 hours after 20µMol ADP, TRAP, Arachidonic acid, Collagen [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).
Percentage IPA at 8 hours after 20µMol ADP, TRAP, Arachidonic acid, Collagen [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).
periprocedural bleeding [0~24 hours]
Periprocedural bleeding will be monitored and described according to BARC and TIMI definition
Peak cardiac enzyme level [0~24 hours]
From blood samples at 0, 2H, 8H and 24H, CK-MB and Troponin I will be measured
Percentage IPA after TRAP, arachidonic acid, collagen at 2 hours [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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