Comparison of Antiplatelet Effect of Ticagrelor vs Tirofiban in Patients With Non-ST Elevation Acute Coronary Syndrome
NCT ID: NCT01660373
Last Updated: 2012-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2012-08-31
2013-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ticagrelor
loading dose(180mg) followed by maintenance dose(90mg bid)
Ticagrelor
loading dose(180mg) followed by maintenance dose(90mg bid)
Tirofiban
0.4ug/kg/min for 30min followed by 0.1ug/kg/min
Tirofiban
0.4ug/kg/min for 30min followed by 0.1ug/kg/min
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tirofiban
0.4ug/kg/min for 30min followed by 0.1ug/kg/min
Ticagrelor
loading dose(180mg) followed by maintenance dose(90mg bid)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Pusan National University Yangsan Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
June Hong Kim
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
June Hong Kim, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Yangsan Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pusan National University Yangsan Hospital
Yangsan, Kyeongsangnamdo, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
June Hong Kim, MD, PhD
Role: primary
Dongcheul Han, MD
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ISSBRIL0080
Identifier Type: -
Identifier Source: org_study_id