Intracoronary Tirofiban on No-Reflow Phenomena

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

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).

Study Overview

• Status: Completed
• Conditions: No-Reflow Phenomenon
• Intervention / Treatment: Drug: Tirofiban; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey, 38039
    • Erciyes University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: February 1, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Estimate): February 4, 2014
• Last Update Submitted That Met QC Criteria: February 1, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: No-reflow phenomenon, tirofiban, intracoronary
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; No-Reflow Phenomenon; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Tirofiban
• Other Study ID Numbers: Makpek-2