Non-ST Elevation Myocardial InfarctionPhase 4NCT03114995

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

A Phase 4 study testing Tirofiban in people with Non-ST Elevation Myocardial Infarction, run by Seoul National University Bundang Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 19 to 85 years
Conditions the study is for: Non-ST Elevation Myocardial Infarction
What is being tested?: Tirofiban
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: No sites listed yet
Study dates: 1 Feb 2012to 1 Oct 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: Effect of Tailored Use of Tirofiban in Patients With Non-ST-elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

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.

Read the detailed description

Some patients have a poor response to dual antiplatelet therapy (DAPT), and it can result in a poor prognosis after percutaneous coronary intervention (PCI). Devices like Ultegra Rapid Platelet Function Analyzer (VerifyNow®) enable us to quantify platelet reactivity quickly in the catheter laboratory. This means that the poor responders to DAPT can be identified, and the patients' outcomes can be improved by providing additional antiplatelet agents. Tirofiban, a GP IIb/IIIa inhibitor, is a potent antiplatelet agent which is recommended for Non-ST-Elevation acute coronary syndrome (NSTE-ACS) with high risk at presentation. However, its role is not clear for patients stabilized with standard medical treatment but with a poor responsiveness to DAPT.

In this study, Investigators administered tirofiban on top of DAPT to patients with NSTE-ACS undergoing PCI who have a high platelet reactivity (HPR) identified by VerifyNow.

To the best of our knowledge, there are few studies conducted with tirofiban for tailored antiplatelet therapy. Moreover, this is the first randomized study with NSTE-ACS patients for tailored use of tirofiban under the guidance of platelet reactivity.

Conditions: Non-ST Elevation Myocardial Infarction
Being tested: Tirofiban
Keywords: Tirofiban, Resistance to antiplatelet agents
Medical subject headings: Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TirofibanDrug
Also called Agrastat

Study groups in NCT03114995
Study group	Role	What they receive
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 Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

Percentage of Participants With Periprocedural Myonecrosis
Percentage of participants with periprocedural myonecrosis under the criteria described below.
When the cardiac biomarkers before the procedure were within the 99th percentile upper reference limit (URL), more than a 5-fold elevation in the URL within 12 hours after percutaneous coronary intervention (PCI) was defined as periprocedural myonecrosis. If the cardiac biomarker level was already above the 99th percentile URL before the procedure and the trend was stationary or decreasing, a ≥20% increase compared to the previous level was considered periprocedural myonecrosis. If the trend was still increasing, the levels at the post-6 hour and 12-hour were compared to determine periprocedural myonecrosis.
Measured: 0,6,12,18,24,30,36 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20121 Oct 2015

First posted14 Apr 2017
Study start1 Feb 2012
Primary completion1 Oct 2015
Study completion1 Oct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Non-ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03114995
Sponsor's protocol ID: B-1111-140-001
Status last verified: Jun 2018
First submitted: 11 Apr 2017
Last updated: 17 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: not planned

Publications

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.
PubMed 18804738
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.
PubMed 10595951
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.
PubMed 19264239
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.
PubMed 19231326
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.
PubMed 18645057
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.
PubMed 18549843
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.
PubMed 21232664
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.
PubMed 30348101

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
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Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
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Active, not recruiting
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
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Acute Coronary Syndromes, Chest Pain

All Non-ST Elevation Myocardial Infarction trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Tailored Use of Tirofiban in Patients With Non-ST-elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
ClinicalTrials.gov ID: NCT03114995
Acronym / sponsor ID: B-1111-140-001
Conditions: Non-ST Elevation Myocardial Infarction
Keywords: Tirofiban, Resistance to antiplatelet agents
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Seoul National University Bundang HospitalUniversity, hospital or other
Study start: 1 Feb 2012 (actual)
Primary completion: 1 Oct 2015 (actual)
Study completion: 1 Oct 2015 (actual)
First posted: 14 Apr 2017 (actual)
Results: Posted 8 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

In this study, Investigators administered tirofiban on top of DAPT to patients with NSTE-ACS undergoing PCI who have a high platelet reactivity (HPR) identified by VerifyNow.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
Group A (high platelet reactivity - tirofiban)	Experimental	Drug: TirofibanPatients 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
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

Who may qualify

Ages: 19 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

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
TirofibanAlso: Agrastat	Drug	Group A (high platelet reactivity - tirofiban)

Primary outcome

Area Under Curve of Serial Cardiac Biomarkers
Time frame: 0,6,12,18,24,30,36 hours
An area under the curve of serial levels of Troponin I and creatine kinase-MB isoenzyme during 36 hours

1 secondary outcome

Percentage of Participants With Periprocedural Myonecrosis
Time frame: 0,6,12,18,24,30,36 hours

Results and safety

Results posted to the registry on 8 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A (High Platelet Reactivity - Tirofiban)	31	30
Control C1 (High Platelet Reactivity - no Tirofiban)	31	30
Control C2(Low Platelet Reactivity - no Tirofiban)	78	78

Primary outcome: Area Under Curve of Serial Cardiac Biomarkers

Time frame: 0,6,12,18,24,30,36 hours. Median (Inter-Quartile Range). Unit: Hours*ng/ml

Measure	Group A (High Platelet Reactivity - Tirofiban) n = 30	Control C1 (High Platelet Reactivity - no Tirofiban) n = 30	Control C2 (Low Platelet Reactivity - no Tirofiban) n = 78
Troponin I	197.2 (41.5 to 395.7)	38.0 (8.9 to 313.9)	121.4 (43.7 to 481.8)
creatine kinase-MB isoenzyme	252.5 (48.0 to 470.1)	92.7 (39.1 to 402.1)	185.6 (79.8 to 425.3)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A (High Platelet Reactivity - Tirofiban)	0 of 30 (0%)	4 of 30 (13.3%)	2 of 30
Control C1 (High Platelet Reactivity - no Tirofiban)	0 of 30 (0%)	1 of 30 (3.3%)	0 of 30
Control C2 (Low Platelet Reactivity - no Tirofiban)	0 of 78 (0%)	8 of 78 (10.3%)	0 of 78

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 18804738Patti 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.
Results publication: PubMed 10595951Hong 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.
Results publication: PubMed 19264239Fung 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.
Results publication: PubMed 19231326De 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.
Results publication: PubMed 18645057Jeremias 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.
Results publication: PubMed 18549843Cuisset 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.
Results publication: PubMed 21232664Suh 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.
Derived from this study: PubMed 30348101Lee 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.
Individual participant dataSharing planned: No. not planned

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Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
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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.

Tae-Jin Youn, PhD principal investigator

Seoul National University Bundang Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tirofiban in people with Non-ST Elevation Myocardial Infarction, run by Seoul National University Bundang Hospital.

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 2 inclusion and 4 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: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under Curve of Serial Cardiac Biomarkers (time frame: 0,6,12,18,24,30,36 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 NCT03114995, which also lists 8 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 17 Jul 2018.