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
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COMPLETED
PHASE4
162 participants
INTERVENTIONAL
2011-01-31
2013-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Tirofiban
Intracoronary administering of Tirofiban
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
Placebo
Intracoronary serum physiologic
Interventions
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Tirofiban
Intracoronary administering of Tirofiban
Placebo
Intracoronary serum physiologic
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
90 Years
ALL
No
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Mahmut Akpek
Medical doctor of Cardiology department
Locations
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Erciyes University School of Medicine
Kayseri, , Turkey (Türkiye)
Countries
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Other Identifiers
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Makpek-2
Identifier Type: -
Identifier Source: org_study_id
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