Back to resultsComparison of Antiplatelet Effect of Ticagrelor vs Tirofiban in Patients With Non-ST Elevation Acute Coronary Syndrome (TE-CLOT)
Primary Purpose
Non-ST Segment Elevation Acute Coronary Syndrome
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tirofiban
Ticagrelor
Sponsored by
About this trial
This is an interventional treatment trial for Non-ST Segment Elevation Acute Coronary Syndrome focused on measuring ticagrelor, tirofiban, glycoprotein IIa/IIIa inhibitors, P2Y12 blockers, acute coronary syndrome
Eligibility Criteria
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
Sites / Locations
- Pusan National University Yangsan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ticagrelor
Tirofiban
Arm Description
loading dose(180mg) followed by maintenance dose(90mg bid)
0.4ug/kg/min for 30min followed by 0.1ug/kg/min
Outcomes
Primary Outcome Measures
Percentage IPA after 20µmol/l ADP at 2 hour
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
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
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
Periprocedural bleeding will be monitored and described according to BARC and TIMI definition
Peak cardiac enzyme level
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
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).
Full Information
NCT ID
NCT01660373
First Posted
August 5, 2012
Last Updated
December 16, 2012
Sponsor
Pusan National University Yangsan Hospital
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT01660373
Brief Title
Comparison of Antiplatelet Effect of Ticagrelor vs Tirofiban in Patients With Non-ST Elevation Acute Coronary Syndrome
Acronym
TE-CLOT
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 Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital
Collaborators
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ST Segment Elevation Acute Coronary Syndrome
Keywords
ticagrelor, tirofiban, glycoprotein IIa/IIIa inhibitors, P2Y12 blockers, acute coronary syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
loading dose(180mg) followed by maintenance dose(90mg bid)
Arm Title
Tirofiban
Arm Type
Active Comparator
Arm Description
0.4ug/kg/min for 30min followed by 0.1ug/kg/min
Intervention Type
Drug
Intervention Name(s)
Tirofiban
Intervention Description
0.4ug/kg/min for 30min followed by 0.1ug/kg/min
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
loading dose(180mg) followed by maintenance dose(90mg bid)
Primary Outcome Measure Information:
Title
Percentage IPA after 20µmol/l ADP at 2 hour
Description
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).
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Percentage IPA at 8 hours after 20µMol ADP, TRAP, Arachidonic acid, Collagen
Description
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).
Time Frame
8 hours
Title
Percentage IPA at 8 hours after 20µMol ADP, TRAP, Arachidonic acid, Collagen
Description
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).
Time Frame
24 hours
Title
periprocedural bleeding
Description
Periprocedural bleeding will be monitored and described according to BARC and TIMI definition
Time Frame
0~24 hours
Title
Peak cardiac enzyme level
Description
From blood samples at 0, 2H, 8H and 24H, CK-MB and Troponin I will be measured
Time Frame
0~24 hours
Title
Percentage IPA after TRAP, arachidonic acid, collagen at 2 hours
Description
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).
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
June Hong Kim, MD,PhD
Phone
+82-10-8231-7171
Email
junehongk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dongcheul Han, MD
Phone
+82-10-2992-6270
Email
usdoc12@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
June Hong Kim, MD,PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Kyeongsangnamdo
ZIP/Postal Code
626-770
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
June Hong Kim, MD, PhD
Phone
+82-10-8231-7171
Email
junehongk@gmail.com
First Name & Middle Initial & Last Name & Degree
Dongcheul Han, MD
Phone
+82-10-2992-6270
Email
usdoc12@gmail.com
First Name & Middle Initial & Last Name & Degree
June Hong Kim, MD,PhD
First Name & Middle Initial & Last Name & Degree
Dongcheul Han, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
22809746
Citation
Jneid H, Anderson JL, Wright RS, Adams CD, Bridges CR, Casey DE Jr, Ettinger SM, Fesmire FM, Ganiats TG, Lincoff AM, Peterson ED, Philippides GJ, Theroux P, Wenger NK, Zidar JP. 2012 ACCF/AHA focused update of the guideline for the management of patients with unstable angina/non-ST-elevation myocardial infarction (updating the 2007 guideline and replacing the 2011 focused update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2012 Aug 14;60(7):645-81. doi: 10.1016/j.jacc.2012.06.004. Epub 2012 Jul 16. No abstract available.
Results Reference
background
PubMed Identifier
19923168
Citation
Gurbel PA, Bliden KP, Butler K, Tantry US, Gesheff T, Wei C, Teng R, Antonino MJ, Patil SB, Karunakaran A, Kereiakes DJ, Parris C, Purdy D, Wilson V, Ledley GS, Storey RF. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study. Circulation. 2009 Dec 22;120(25):2577-85. doi: 10.1161/CIRCULATIONAHA.109.912550. Epub 2009 Nov 18.
Results Reference
background
PubMed Identifier
19717846
Citation
Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
Results Reference
background
PubMed Identifier
20048389
Citation
Saltzman AJ, Mehran R, Hooper WC, Moses JW, Weisz G, Collins MB, Lansky AJ, Kreps EM, Leon MB, Stone GW, Dangas G. The relative effects of abciximab and tirofiban on platelet inhibition and C-reactive protein during coronary intervention. J Invasive Cardiol. 2010 Jan;22(1):2-6.
Results Reference
background
PubMed Identifier
26581884
Citation
Kim JS, Han DC, Jeong YH, Park DW, Sohn CB, Hwang KW, Lee SH, Choi JH, Chon MK, Lee SY, Hwang J, Kim IS, Lee SM, Han J, Noh M, Kim CH, Chun KJ, Park YH, Kim JH. Antiplatelet effect of ticagrelor compared to tirofiban in non-ST-segment elevation ACS patients undergoing PCI. The result of the TE-CLOT trial. Thromb Haemost. 2016 Jan;115(1):213-21. doi: 10.1160/TH15-02-0180. Epub 2015 Nov 19.
Results Reference
derived
Learn more about this trial
Comparison of Antiplatelet Effect of Ticagrelor vs Tirofiban in Patients With Non-ST Elevation Acute Coronary Syndrome
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