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Intracoronary Tirofiban on No-Reflow Phenomena

Sponsor
TC Erciyes University (Other)
Overall Status
Completed
CT.gov ID
NCT02054000
Collaborator
(none)
162
Enrollment
1
Location
2
Arms
35
Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study was to evaluate the acute effect of intracoronary administration of tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow phenomenon undergoing primary percutaneous coronary intervention (PCI).

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The no-reflow phenomenon is one of the most common causes of adverse cardiovascular events in patients with ST-elevated myocardial infarction (STEMI). Re-canalization of infarct related arterial (IRA) flow related to better ventricular performance and lower mortality rate in patients with STEMI. In addition, no-reflow phenomena may limit the benefits of re-canalization of the IRA.

In recent years, many mechanical or pharmacological treatment strategies including adjunctive administration of glycoprotein IIb/IIIa inhibitors (GPI) have been proposed in patients with STEMI. Although current guidelines recommend that small molecule GPI should be administered as an upstream bolus followed by a continuous infusion in patients with STEMI, changes in clinical practice may obviate the need for GPI dosage or routes in current practice. Previous studies have shown that intravenous and intracoronary administration of GPI improve the prognosis and significantly reduce mortality in patients with STEMI. Recently, the Ongoing Tirofiban in Myocardial infarction Evaluation-2 (ON-TIME 2) trial found that the use of tirofiban started during the pre-hospital phase as upstream therapy for primary percutaneous coronary intervention (PCI) and continued for up to 18 hours infusion after the procedure showed an improvement in the markers of reperfusion. Additionally, a reduction was demonstrated in the death in recurrent myocardial infarction in urgent target vessel revascularization and thrombotic bailout. However, in the current literature there are insufficient data regarding the role of intracoronary administration of GPI inhibitors in patients with STEMI who developed the no-reflow phenomenon. The goal of this study was to evaluate the acute effect of intracoronary administration of tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow phenomenon undergoing primary PCI.

Study Design

Study Type:
Interventional
Actual Enrollment :
162 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Intracoronary Tirofiban on No-Reflow Phenomena in Patients With ST-Elevated Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Tirofiban group

If thrombolysis in myocardial infarction flow <3 in spite of performed treatments, patients were considered as no-reflow and randomized to tirofiban or placebo group. Intracoronary tirofiban (25 µgr/kg) was administered via the guiding catheter to the infarct related artery

Drug: Tirofiban
Intracoronary administering of Tirofiban
Other Names:
  • Glycoprotein IIb/IIIa inhibitor

    		•
    Placebo Comparator: Placebo group

    If thrombolysis in myocardial infarction flow <3 in spite of performed treatments, patients were considered as no-reflow and randomized to tirofiban or placebo group. Intracoronary serum physiologic as placebo was administered via the guiding catheter to the infarct related artery

    Other: Placebo
    Intracoronary serum physiologic

    Outcome Measures

    Primary Outcome Measures

    1. in-hospital mortality [up to 8 days]

    2. Non-fatal myocardial infarction [up to 8 days]

    3. in-stent thrombosis [up to 8 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with ST-elevated myocardial infarction who developed no-reflow phenomena
    Exclusion Criteria:

    • Treatment with thrombolytic drugs in the previous 24 hours

    • Known malignancy

    • Pain to balloon time >6 hours

    • Uncontrolled hypertension (>180/110 mmHg)

    • Bleeding diathesis

    • Thrombocytopenia

    • End-stage liver disease

    • Cardiogenic shock

    • Renal failure

    • Life expectancy of less than 1 year

    • Contraindication for the use of tirofiban.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Erciyes University School of Medicine Kayseri Turkey 38039

    Sponsors and Collaborators

    • TC Erciyes University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahmut Akpek, Medical doctor of Cardiology department, TC Erciyes University
    ClinicalTrials.gov Identifier:
    NCT02054000
    Other Study ID Numbers:
    • Makpek-2
    First Posted:
    Feb 4, 2014
    Last Update Posted:
    Feb 4, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by Mahmut Akpek, Medical doctor of Cardiology department, TC Erciyes University
    No-reflow phenomenon, tirofiban, intracoronary
    Additional relevant MeSH terms:
    No-Reflow Phenomenon
    Tirofiban

    Study Results

    No Results Posted as of Feb 4, 2014