Intracoronary Tirofiban on No-Reflow Phenomena

No-Reflow Phenomenon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054000
• Other study ID #: Makpek-2
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2014
• Last updated: February 1, 2014
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• No-Reflow Phenomenon

Intervention

Drug:
• Tirofiban
Intracoronary administering of Tirofiban

Other:
• Placebo
Intracoronary serum physiologic

Locations

Country	Name	City	State
Turkey	Erciyes University School of Medicine	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-hospital mortality		up to 8 days	No
Primary	Non-fatal myocardial infarction		up to 8 days	No
Primary	in-stent thrombosis		up to 8 days	No