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

NCT01660373 | Unknown Phase 3 DMC

• 1 other identifier: ISSBRIL0080
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

1. 1.Ticagrelor : loading dose(180mg) followed by maintenance dose(90mg bid)
2. 2.Tirofiban : 0.4ug/kg/min for 30min followed by 0.1ug/kg/min
3. 3.both agents will be given on top of aspirin

Conditions

Non-ST Segment Elevation Acute Coronary Syndrome

Keywords

ticagrelor; tirofiban; glycoprotein IIa/IIIa inhibitors; P2Y12 blockers; acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• 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).

  2 hours

Secondary Outcomes (5)

• Percentage IPA at 8 hours after 20µMol ADP, TRAP, Arachidonic acid, Collagen

  8 hours

• Percentage IPA at 8 hours after 20µMol ADP, TRAP, Arachidonic acid, Collagen

  24 hours

• periprocedural bleeding

  0~24 hours

• Peak cardiac enzyme level

  0~24 hours

• Percentage IPA after TRAP, arachidonic acid, collagen at 2 hours

  2 hours

Study Arms (2)

Ticagrelor

EXPERIMENTAL

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

Drug: Ticagrelor

Tirofiban

ACTIVE COMPARATOR

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

Drug: Tirofiban

Interventions

Tirofiban DRUG

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

Tirofiban

Ticagrelor DRUG

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

Ticagrelor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Kyeongsangnamdo, 626-770, South Korea

RECRUITING

Related Publications (5)

• 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.

  PMID: 22809746 BACKGROUND

• 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.

  PMID: 19923168 BACKGROUND

• 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.

  PMID: 19717846 BACKGROUND

• 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.

  PMID: 20048389 BACKGROUND

• 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.

  PMID: 26581884 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Tirofiban; Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• June Hong Kim, MD,PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

June Hong Kim, MD,PhD

CONTACT

+82-10-8231-7171; junehongk@gmail.com

Dongcheul Han, MD

CONTACT

+82-10-2992-6270; usdoc12@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2012
• First Posted: August 8, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 18, 2012

Record last verified: 2012-12

Locations

KR (1)