Tailored Use of Tirofiban for Non-ST-elevation Acute Coronary Syndrome Patients

NCT03114995 | Completed Phase 4 Results

• 1 other identifier: B-1111-140-001
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigators aimed to test the beneficial effect of tirofiban, a GPIIb/IIIa antagonist, for Non-ST-Elevation Acute Coronary Syndrome Patients who has high resistance to clopidogrel.

Conditions

Non-ST Elevation Myocardial Infarction

Keywords

Tirofiban; Resistance to antiplatelet agents

Outcome Measures

Primary Outcomes (1)

• Area Under Curve of Serial Cardiac Biomarkers

  An area under the curve of serial levels of Troponin I and creatine kinase-MB isoenzyme during 36 hours

  0,6,12,18,24,30,36 hours

Secondary Outcomes (1)

• Percentage of Participants With Periprocedural Myonecrosis

  0,6,12,18,24,30,36 hours

Study Arms (3)

Group A (high platelet reactivity - tirofiban)

EXPERIMENTAL

Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h

Drug: Tirofiban

Control C1 (high platelet reactivity - no tirofiban)

NO INTERVENTION

Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered

Control C2 (low platelet reactivity - no tirofiban)

NO INTERVENTION

Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered

Interventions

Tirofiban DRUG

Also known as: Agrastat

Group A (high platelet reactivity - tirofiban)

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with NSTE-ACS who need PCI
• loaded with aspirin and clopidogrel at least 6 h before the procedure

You may not qualify if:

• thrombocytopenia (platelet count \<100,000/μL)
• history of hemorrhagic stroke
• history of ischemic stroke in the recent 2 year
• history of major surgery 6 months prior

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Related Publications (8)

• Patti G, Nusca A, Mangiacapra F, Gatto L, D'Ambrosio A, Di Sciascio G. Point-of-care measurement of clopidogrel responsiveness predicts clinical outcome in patients undergoing percutaneous coronary intervention results of the ARMYDA-PRO (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty-Platelet Reactivity Predicts Outcome) study. J Am Coll Cardiol. 2008 Sep 30;52(14):1128-33. doi: 10.1016/j.jacc.2008.06.038.

  PMID: 18804738 RESULT

• Hong MK, Mehran R, Dangas G, Mintz GS, Lansky AJ, Pichard AD, Kent KM, Satler LF, Stone GW, Leon MB. Creatine kinase-MB enzyme elevation following successful saphenous vein graft intervention is associated with late mortality. Circulation. 1999 Dec 14;100(24):2400-5. doi: 10.1161/01.cir.100.24.2400.

  PMID: 10595951 RESULT

• Fung AY, Saw J, Starovoytov A, Densem C, Jokhi P, Walsh SJ, Fox RS, Humphries KH, Aymong E, Ricci DR, Webb JG, Hamburger JN, Carere RG, Buller CE. Abbreviated infusion of eptifibatide after successful coronary intervention The BRIEF-PCI (Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention) randomized trial. J Am Coll Cardiol. 2009 Mar 10;53(10):837-45. doi: 10.1016/j.jacc.2008.09.060.

  PMID: 19264239 RESULT

• De Labriolle A, Lemesle G, Bonello L, Syed AI, Collins SD, Ben-Dor I, Pinto Slottow TL, Xue Z, Torguson R, Suddath WO, Satler LF, Kent KM, Pichard AD, Lindsay J, Waksman R. Prognostic significance of small troponin I rise after a successful elective percutaneous coronary intervention of a native artery. Am J Cardiol. 2009 Mar 1;103(5):639-45. doi: 10.1016/j.amjcard.2008.10.044. Epub 2009 Jan 17.

  PMID: 19231326 RESULT

• Jeremias A, Kleiman NS, Nassif D, Hsieh WH, Pencina M, Maresh K, Parikh M, Cutlip DE, Waksman R, Goldberg S, Berger PB, Cohen DJ; Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) Registry Investigators. Prevalence and prognostic significance of preprocedural cardiac troponin elevation among patients with stable coronary artery disease undergoing percutaneous coronary intervention: results from the evaluation of drug eluting stents and ischemic events registry. Circulation. 2008 Aug 5;118(6):632-8. doi: 10.1161/CIRCULATIONAHA.107.752428. Epub 2008 Jul 21.

  PMID: 18645057 RESULT

• Cuisset T, Hamilos M, Sarma J, Sarno G, Wyffels E, Vanderheyden M, Barbato E, Bartunek J, De Bruyne B, Wijns W. Relation of low response to clopidogrel assessed with point-of-care assay to periprocedural myonecrosis in patients undergoing elective coronary stenting for stable angina pectoris. Am J Cardiol. 2008 Jun 15;101(12):1700-3. doi: 10.1016/j.amjcard.2008.02.054. Epub 2008 Apr 18.

  PMID: 18549843 RESULT

• Suh JW, Lee SP, Park KW, Lee HY, Kang HJ, Koo BK, Cho YS, Youn TJ, Chae IH, Choi DJ, Rha SW, Bae JH, Kwon TG, Bae JW, Cho MC, Kim HS. Multicenter randomized trial evaluating the efficacy of cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease: results of the CILON-T (influence of CILostazol-based triple antiplatelet therapy ON ischemic complication after drug-eluting stenT implantation) trial. J Am Coll Cardiol. 2011 Jan 18;57(3):280-9. doi: 10.1016/j.jacc.2010.08.631.

  PMID: 21232664 RESULT

• Lee W, Suh JW, Park JJ, Yoon CH, Cho YS, Youn TJ, Chae IH. Effect of tailored use of tirofiban in patients with Non-ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention: a randomized controlled trial. BMC Cardiovasc Disord. 2018 Oct 22;18(1):201. doi: 10.1186/s12872-018-0938-6.

  PMID: 30348101 DERIVED

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Interventions

Tirofiban

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The difference in the distribution of PRU values of subjects estimated from previous literatures leading to small numbers of subjects assigned to the study group

Results Point of Contact

• Title: Dr. Tae-Jin Youn
• Organization: Cardiovascular Center, Seoul National University Bundang Hospital

ytjmd@snubh.org

+82-31-787-7031

Study Officials

• Tae-Jin Youn, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Cardiovascular Center

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 14, 2017
• Study Start: February 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: July 17, 2018
• Results First Posted: June 8, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share