Non-ST Segment Elevation Acute Coronary SyndromePhase 3TE-CLOTNCT01660373
Comparison of Antiplatelet Effect of Ticagrelor vs Tirofiban in Patients With Non-ST Elevation Acute Coronary Syndrome
A Phase 3 study testing Tirofiban and Ticagrelor in people with Non-ST Segment Elevation Acute Coronary Syndrome, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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 1. Ticagrelor : loading dose(180mg) followed by maintenance dose(90mg bid) 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-ST Segment Elevation Acute Coronary Syndrome
- What is being tested?
- Tirofiban and Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, Kyeongsangnamdo, 626-770
June Hong Kim, MD, PhD, +82-10-8231-7171, junehongk@gmail.com
Dongcheul Han, MD, +82-10-2992-6270, usdoc12@gmail.com
About this study
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
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
Read the 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
- Being tested
- Tirofiban, Ticagrelor
- Keywords
- ticagrelor, tirofiban, glycoprotein IIa/IIIa inhibitors, P2Y12 blockers, acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirofibanDrug
0.4ug/kg/min for 30min followed by 0.1ug/kg/min
TicagrelorDrug
loading dose(180mg) followed by maintenance dose(90mg bid)
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | loading dose(180mg) followed by maintenance dose(90mg bid) Receives: Drug: Ticagrelor |
| Tirofiban | Active comparator | 0.4ug/kg/min for 30min followed by 0.1ug/kg/min Receives: Drug: Tirofiban |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 hours
Secondary outcomes (5)
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).
Measured: 8 hours
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).
Measured: 24 hours
periprocedural bleeding
Periprocedural bleeding will be monitored and described according to BARC and TIMI definition
Measured: 0~24 hours
Peak cardiac enzyme level
From blood samples at 0, 2H, 8H and 24H, CK-MB and Troponin I will be measured
Measured: 0~24 hours
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).
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-ST Segment Elevation Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, June Hong Kim, Pusan National University Yangsan Hospital
- Investigators
- June Hong Kim, MD,PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660373
- Sponsor's protocol ID
- ISSBRIL0080
- Acronym
- TE-CLOT
- Status last verified
- Dec 2012
- First submitted
- 5 Aug 2012
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22809746Gurbel 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.
PubMed 19923168Wallentin 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.
PubMed 19717846Saltzman 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.
PubMed 20048389Kim 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.
PubMed 26581884
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01660373
- Acronym / sponsor ID
- TE-CLOT / ISSBRIL0080
- Keywords
- ticagrelor, tirofiban, glycoprotein IIa/IIIa inhibitors, P2Y12 blockers, acute coronary syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: Ticagrelorloading dose(180mg) followed by maintenance dose(90mg bid) |
| Tirofiban | Active comparator | Drug: Tirofiban0.4ug/kg/min for 30min followed by 0.1ug/kg/min |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tirofiban0.4ug/kg/min for 30min followed by 0.1ug/kg/min | Drug | Tirofiban |
| Ticagrelorloading dose(180mg) followed by maintenance dose(90mg bid) | Drug | Ticagrelor |
Primary outcome
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).
5 secondary outcomes
Percentage IPA at 8 hours after 20µMol ADP, TRAP, Arachidonic acid, Collagen
Time frame: 8 hours
Percentage IPA at 8 hours after 20µMol ADP, TRAP, Arachidonic acid, Collagen
Time frame: 24 hours
periprocedural bleeding
Time frame: 0~24 hours
Peak cardiac enzyme level
Time frame: 0~24 hours
Percentage IPA after TRAP, arachidonic acid, collagen at 2 hours
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
- Background: PubMed 22809746Jneid 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.
- Background: PubMed 19923168Gurbel 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.
- Background: PubMed 19717846Wallentin 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.
- Background: PubMed 20048389Saltzman 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.
- Derived from this study: PubMed 26581884Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
June Hong Kim, MD,PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tirofiban and Ticagrelor in people with Non-ST Segment Elevation Acute Coronary Syndrome, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact June Hong Kim, MD,PhD (+82-10-8231-7171, junehongk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage IPA after 20µmol/l ADP at 2 hour (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01660373, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.