Intracoronary Tirofiban on No-Reflow Phenomena

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Effectiveness of Intracoronary Tirofiban on No-Reflow Phenomena in Patients With ST-Elevated Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Conditions
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No-Reflow Phenomenon

Intervention / Treatment
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* Drug: Tirofiban
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tirofiban group<br>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<br>* Intracoronary administering of Tirofiban<br>* Other names: Glycoprotein IIb/IIIa inhibitor;|
| Placebo Comparator: Placebo group<br>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<br>* Intracoronary serum physiologic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-hospital mortality |  | up to 8 days | 
| Non-fatal myocardial infarction |  | up to 8 days | 
| in-stent thrombosis |  | up to 8 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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No-reflow phenomenon, tirofiban, intracoronary